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| | OneTouch SureStep Test Strips (LifeScan): Recall | OneTouch SureStep Test Strips (LifeScan): Recall
Audience: Diabetes healthcare professionals, consumers
LifeScan and FDA notified healthcare professionals of a voluntary recall of eight lots of OneTouch SureStep Test Strips, used by people with diabetes to measure their blood glucose levels at home. The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL. If patients use the falsely low test results to determine their insulin dose, they may give themselves too little insulin, which could result in poor blood glucose control. High blood glucose must be recognized and treated promptly to avoid serious complications, such as coma and death. The eight lots of consumer OneTouch SureStep Test Strips being recalled are identified in the firm's press release. Lot numbers are located on the outer carton and test strip vial. LifeScan estimates approximately fourteen thousand packages (50- and 100-count) of consumer OneTouch SureStep Test Strips were distributed nationwide between August 1, 2009 and January 28, 2010. It is important that patients with recalled test strips continue to test their blood glucose. Patients with access to a meter that does not use OneTouch SureStep Test Strips should use this other meter to test their blood glucose until replacement product from LifeScan arrives. If an alternate meter is not available, patients may continue to test using the recalled OneTouch SureStep Test Strips. However, if patients obtain results above 400 mg/dL, they should contact their healthcare professional for further instructions because their glucose may be significantly higher. Read the complete MedWatch 2010 Safety summary, including a link to the firm's press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm202254.htm | 3/5/2010 4:05 PM | Shujin | | | Invirase (saquinavir): Ongoing safety review of clinical trial data | Invirase (saquinavir): Ongoing safety review of clinical trial data
Audience: HIV/AIDS and cardiological healthcare professionals, patients
FDA notified healthcare professionals and patients that it is reviewing clinical trial data about a potentially serious effect on the heart from the use of Invirase (saquinavir) in combination with Norvir (ritonavir), antiviral medications given together to treat HIV infection. The data suggest that together the two drugs may affect the electrical activity of the heart, known as prolonged QT or PR intervals. A prolonged QT interval can increase the risk for a serious abnormal rhythm called torsades de pointes. A prolonged PR interval can cause the electrical signal responsible for generating a heart beat to slow or even stop, known as heart block. FDA's analysis of these data is ongoing. The agency will update the public as soon as this review is complete. However, healthcare professionals should be aware of this potential risk for changes to the electrical activity of the heart. Invirase and Norvir should not be used in patients already taking medications known to cause QT interval prolongation such as Class IA (such as quinidine,) or Class III (such as amiodarone) antiarrhythmic drugs, or in patients with a history of QT interval prolongation. Patients should not stop taking their prescribed antiviral medications. Patients who are concerned about possible risks associated with using Invirase and Norvir should talk to their healthcare professional. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
• Online: www.fda.gov/MedWatch/report.htm
• Phone: 1-800-332-1088
• Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
• Fax: 1-800-FDA-0178
Read the complete MedWatch 2010 Safety summary, including a link to the Drug Safety communication and News Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm201563.htm | 3/5/2010 4:05 PM | Shujin | | | Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall | Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall
Audience: Nephrology healthcare professionals, patients
FDA and Baxter notified healthcare professionals of a Class I recall of the HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems, which are prescription medical devices used to treat pediatric and adult patients with kidney failure. Reports of serious injuries and at least one death have been associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity. IIPV may result in serious injury or death from conditions including but not limited to: abdominal wall and/or diaphragmatic hernias, hydrothorax, heart failure, acute hypertension, pulmonary edema, decreased pulmonary function, pericardial effusion, and peritonitis. Children and non-verbal patients may be at increased risk because of their smaller size or inability to communicate. Increased monitoring of these patients is recommended. Other vulnerable populations include critically ill patients and patients with pulmonary and hemodynamic instability. Patients and caregivers should watch for the potential signs of IIPV. If patients or caregivers notice any of the signs of IIPV, stop the device, initiate manual drain, and contact your doctor immediately. Clinicians should weigh the risks and benefits to continued use of these devices by their patients versus other forms of dialysis therapy. Clinicians should also review the prescription settings for patients who continue to use these devices. See the Recall Notice for a listing of affected models/product code numbers. Read the MedWatch safety summary, including a link to the Recall Notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm202885.htm | 3/5/2010 4:00 PM | Shujin | | | StatSpin Express 4 Centrifuges Model 510: Class 1 Recall | StatSpin Express 4 Centrifuges Model 510: Class 1 Recall
Audience: Hospital risk managers, laboratory managers
FDA notified healthcare professionals of a Class I recall of the StatSpin Express 4 Centrifuges, Model #510, Serial Numbers 00100 through 001679, manufactured and distributed from November, 2007 through January, 2010. The rotor of the centrifuge may break and separate from the motor, striking a safety microswitch so it fails to shut down the centrifuge. The loose rotor may strike the lid of the centrifuge housing which may cause the lid to open and eject pieces of the rotor. These pieces may cause serious physical injury to bystanders and may expose them to blood-borne infectious micro-organisms. Read the complete MedWatch 2010 Safety summary, including a link to the FDA recall notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm202169.htm | 3/5/2010 4:00 PM | Shujin | | | Transseptal Sheath Introducer Kits: Class I Recall | Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: Class I Recall
Audience: Cardiologists, Hospital Risk Managers
FDA and Thomas Medical Products notified healthcare professionals of a Class I recall of the Transseptal Sheath Introducer Kit (also under the trade names: HeartSpan, CHANNEL FX, Torflex, Braided Guiding Introducer Kit), which are prescription medical devices used to to pass heart catheters from the right to the left side of the heart. The sheath tip may break off and separate during heart procedures. If this occurs, the fragment could move through the heart and arteries to vital organs, causing a blockage anywhere, including the brain or heart. This could lead to unplanned open heart surgery, permanent injury, such as a stroke or heart attack, and/or death. These devices were manufactured and distributed from October 1, 2006 through December 27, 2009. Read the MedWatch safety summary, including a link to the Class I Recall Notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm203272.htm | 3/5/2010 3:55 PM | Shujin | | | Avandia (rosiglitazone) | Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety
Audience: Endocrinology, cardiology healthcare professionals, patients
FDA notified healthcare professional and patients that it is reviewing the primary data from a large, long-term clinical study, RECORD, on possible cardiovascular risks with the diabetes drug, Avandia (rosiglitazone). In addition to the clinical trial, a number of observational studies of the cardiovascular safety of rosiglitazone have been published and FDA has been reviewing these on an ongoing basis. These reviews are ongoing and no new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time. Once FDA completes its review of the data from the RECORD study, the agency will present the totality of new and existing cardiovascular safety data on rosiglitazone at a public meeting in July 2010. The Agency will provide an updated assessment of the risks and benefits of rosiglitazone in the treatment of type 2 diabetes. FDA recommends that healthcare professionals follow the recommendations in the drug label when prescribing rosiglitazone. This includes a Boxed Warning. Patients should continue taking rosiglitazone unless told by their healthcare professional to stop. Patients who are concerned about the possible risks associated with using rosiglitazone should talk to their healthcare professional. Read the complete MedWatch 2010 Safety summary, including a link to the Drug Safety communcation, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm201446.htm | 2/22/2010 6:55 PM | Shujin | | | Ear Candles | Ear Candles: Risk of Serious Injuries
Audience: Consumers, Otolaryngological healthcare professionals
FDA is notifying consumers and healthcare providers of its warning not to use ear candles - a hollow cone about 10 inches long made from a fabric tube soaked in beeswax, paraffin or a mixture of the two - because they can cause serious injuries, even when used according to the manufacturer’s directions. According to advertised claims, a burning ear candle draws ear wax and “impurities” or “toxins” out of the ear canal. Other claims for ear candles include relief from sinus and ear infections, headache and earache, as well as improved hearing, “blood purification,” improvements in brain function, and cure cancer. FDA has found no valid scientific evidence to support the safety or effectiveness of these devices for any medical claims or benefits. FDA has received reports of burns, perforated eardrums and blockage of the ear canal which required outpatient surgery from the use of ear candles. FDA is especially concerned because some ear candles are being advertised for use in children. Children of any age, including babies, are likely at increased risk for injuries and complications if they are exposed to ear candles. Small children and infants may move during the use of the device, increasing the likelihood of wax burns and ear candle wax plugging up the ear canal. Also, their smaller ear canal size may make children more susceptible than adults to injuries. Ear candles are sold and promoted in a variety of locations, including health food stores, flea markets, health spas and salons, as well as on commercial web sites. Consumers and health care professionals are strongly encouraged to report injury related to the use of ear candles to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
• Online: www.fda.gov/MedWatch/report.htm
• Phone: 1-800-332-1088
• Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
• Fax: 1-800-FDA-0178
Read the complete MedWatch 2010 Safety summary, including a link to the FDA Advice for Patients, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm201108.htm | 2/20/2010 10:35 PM | Shujin | | | Asthma LABA Meds | Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements
Audience: Asthma management healthcare professionals, patients
FDA notified healthcare professionals and consumers that, due to safety concerns, FDA is requiring a risk management strategy (REMS) and class-labeling changes for all LABAs. The REMS will require a revised Medication Guide written specifically for patients, and a plan to educate healthcare professionals about the appropriate use of LABAs. These changes are based on FDA's analyses of studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients as well as death in some patients using LABAs for the treatment of asthma. Healthcare professionals are reminded that to ensure the safe use of these products:
• Single-ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone.
• LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications.
• LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved.
Patients should then be maintained on an asthma controller medication.
• Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid
and a LABA, to ensure compliance with both medications.
FDA has determined that the benefits of LABAs in improving asthma symptoms outweigh the potential risks when used appropriately with an asthma controller medication in patients who need the addition of LABAs. FDA believes the safety measures recommended will improve the safe use of these drugs. Read the complete MedWatch 2010 Safety summary, including links to the Drug Safety Communication, Q&As and FDA news release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm201003.htm | 2/18/2010 4:20 PM | Shujin | | | Exjade (deferasirox) | Exjade (deferasirox): Boxed Warning
Audience: Hematology-Oncology healthcare professionals
Novartis Oncology and FDA notified healthcare professionals about recent changes in the Prescribing Information (PI) for Exjade, indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. New language was added to the Contraindications, Warnings and Precautions, and Drug Interactions sections of the PI, including a Boxed Warning, that the product may cause:
• renal impairment, including failure • hepatic impairment, including failure • gastrointestinal hemorrhage
In some reported cases, these reactions were fatal. These reactions were more frequently observed in patients with advanced age, high risk myelodysplastic syndromes, underlying renal or hepatic impairment or low platelet counts. Exjade therapy requires close patient monitoring, including measurement of serum creatinine and/or creatinine clearance as specified in the PI and serum transaminases and bilirubin as specified in the PI. Read the complete MedWatch 2010 Safety summary, including a link to the Dear Healthcare Professional letter and revised Prescribing Information, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm200850.htm | 2/18/2010 4:10 PM | Shujin | | | Procrit, Epogen and Aranesp | Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication
Audience: Oncological and nephrological healthcare professionals and patients
FDA and Amgen notified healthcare professionals and patients that all ESAs must be used under a REMS risk management program. As part of the risk management program, a Medication Guide explaining the risks and benefits of ESAs must be provided to all patients receiving an ESA. Under the ESA APPRISE Oncology program, Amgen will ensure that only those hospitals and healthcare professionals who have enrolled and completed training in the program will prescribe and dispense ESAs to patients with cancer. Amgen is also required to oversee and monitor the program to ensure that hospitals and healthcare professionals are fully compliant with all aspects of the program. FDA is requiring a REMS because studies show that ESAs can increase the risk of tumor growth and shorten survival in patients with cancer who use these products. Studies also show that ESAs can increase the risk of heart attack, heart failure, stroke or blood clots in patients who use these drugs for other conditions. Read the complete MedWatch 2010 Safety summary including links to the Drug Safety Communication and current Prescribing Information for these products, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm200391.htm | 2/17/2010 10:40 PM | Shujin | | | Maalox | Maalox Total Relief and Maalox Liquid Products: Medication Use Errors
Audience: Consumers, Healthcare professionals
FDA notified consumers and healthcare professionals about reports of serious medication errors involving consumers who used Maalox Total Relief when they had intended to use a Maalox liquid antacid product. Maalox Total Relief and the traditional Maalox products are both liquid medications available without a prescription, but are not interchangeable and are intended to treat different medical conditions. Maalox Total Relief is an upset stomach reliever and anti-diarrheal medication, while traditional Maalox liquid products Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are antacids. Maalox Total Relief is not appropriate for individuals who want to use an antacid, since it contains the active ingredient bismuth subsalicylate which is chemically related to aspirin and may cause serious adverse effects such as bleeding. Maalox Total Relief should not be used in people who have or have a history of gastrointestinal ulcers or a bleeding disorder. It also should not be taken by children and teens if they are recovering from a viral infection, nor by individuals who are taking certain medications including: oral antidiabetic drugs (OADs), anticoagulation (thinning the blood) drugs such as warfarin (Coumadin) and clopidogrel (Plavix), non-steroidal anti-inflammatory drugs (NSAIDS), and other anti-inflammatory drugs. The Drug Safety Communication contains additional information for consumers and healthcare professionals, as well as product label photos. Read the complete MedWatch 2010 Safety summary, including links to the Drug Safety Communication and FDA news release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm200672.htm | 2/17/2010 10:35 PM | Shujin | | | Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall | Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall
Audience: Emergency medical professionals, hospital risk managers
Cardiac Science Corporation and FDA notified healthcare professionals and consumers of a recall because the automated external defibrillator (AED) may not be able to deliver therapy during a cardiac resuscitation attempt, which may lead to serious adverse events or death. These AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions. Each of the approximately 12,200 devices affected in this recall can be confirmed at the Cardiac Science Web site, www.cardiacscience.com/AED195. The affected AEDs were manufactured or serviced between October 19, 2009 and January 15, 2010 and include the following models - Powerheart 9300A, 9300E, 9300P, 9390A, 9390E, CardioVive 92532 and CardioLife 9200G and 9231. Each affected AED should immediately be removed from service since it may not deliver the expected therapy. Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm200138.htm | 2/9/2010 8:25 PM | Shujin | | | BD Q-Syte Luer Access Devices: Recall | BD Q-Syte Luer Access Devices: Recall
BD Q-Syte Luer Access Devices
BD Nexiva Closed IV Catheter Systems
Acacia IV Extension Sets with BD Q-Syte Luer Access Device
Audience: Hospital risk managers, nursing services managers
BD, Acacia Inc. (known as MPS Acacia), and FDA notified healthcare professionals of the recall of certain lots of these devices. The BD Q-Syte Luer Access Device is a needleless valve manufactured by BD, intended for use with other infusion therapy products in the administration of fluids into the intravenous system. Use of the recalled devices may cause an air embolism or leakage of blood or therapeutic product which may result in serious injury or death. The REF/catalog and lot numbers which were sold in the US are noted in the firm's press release. The affected lots were distributed from November 2008 through November 2009. Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178]. Read the complete MedWatch 2010 Safety summary, including links to both firm's press releases, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm200137.htm | 2/9/2010 8:20 PM | Shujin | | | Tysabri (Natalizumab) | Tysabri (Natalizumab): Risk of developing progressive multifocal leukoencephalopathy (PML) increases with increasing duration of exposure to Tysabri
Audience: Neurological healthcare professionals, patients
FDA notified healthcare professionals and patients that the risk of developing progressive multifocal leukoencephalopathy (PML) increases with the number of Tysabri infusions received. This new safety information, based on reports of 31 confirmed cases of PML received by the FDA as of January 21, 2010, will now be included in the Tysabri drug label and patient Medication Guide. Information about the occurrence of Immune Reconstitution Inflammatory Syndrome (IRIS) in patients who have developed PML and subsequently discontinued Tysabri has also been added to the drug label. IRIS is a rare condition characterized by a severe inflammatory response that can occur during or following immune system recovery, causing an unexpected decline in a patient’s condition after return of immune function. Based on the available information, FDA believes that the clinical benefits of Tysabri continue to outweigh the potential risks. Revisions to the drug label and patient Medication Guide, with the continued use of the TOUCH Prescribing Program, are intended to maximize the safe use of Tysabri and the identification of new PML cases. Read the MedWatch 2010 safety summary, including a link to the FDA Drug Safety Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199965.htm | 2/6/2010 6:40 PM | Shujin | | | Hemostatic Introducer System | Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical
Audience: Interventional cardiology healthcare professionals
FDA and Thomas Medical Products Inc. notified healthcare professionals of a Class I Recall of certain lots of the product, tube-like devices placed into blood vessels to insert pacing or defibrillator wires and catheters into blood vessels. The sheath tip may break off and separate while the sheath is inside a blood vessel. If this occurs, the sheath tip could move through the blood vessel into organs such as the lungs and heart or, less commonly, into arteries. From there, the broken tip could cause a blockage anywhere, including the brain or heart, leading to permanent injury, such as a stroke or heart attack, or even death. Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178]. Read the complete MedWatch 2010 Safety summary, including a link to the FDA recall notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199927.htm | 2/4/2010 6:45 PM | Shujin | | | Videx/Videx EC (didanosine) | Videx/Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal Hypertension
Audience - HIV/AIDS, Infectious Disease healthcare professionals
FDA notified healthcare professionals and patients about a rare, but serious, complication in the liver known as non-cirrhotic portal hypertension in patients using Videx or Videx EC (didanosine), a medication used to treat human immunodeficiency virus (HIV) infection. FDA became aware of cases of non-cirrhotic portal hypertension through adverse event reports submitted to FDA's Adverse Event Reporting System. Based on the number of well-documented cases and exclusion of other causes of portal hypertension such as alcohol-related cirrhosis or hepatitis C, FDA concludes there is an association between use of didanosine and development of non-cirrhotic portal hypertension. Because of the potential severity of portal hypertension, including death from hemorrhaging esophageal varices, FDA has revised the Warning and Precautions section of the didanosine drug label to assure safe use of the medication. FDA believes the clinical benefits of didanosine for certain patients with HIV continue to outweigh its potential risks. The decision to use this drug, however, must be made on an individual basis between the treating physician and the patient. Read the complete MedWatch 2010 Safety summary including a link to the Drug Safety Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199343.htm | 1/29/2010 7:45 PM | Shujin | | | Zyprexa (olanzapine) | Zyprexa (olanzapine): Use in Adolescents
Audience: Neuropsychiatric healthcare professionals
Lilly and FDA notified healthcare professionals of changes to the Prescribing Information for Zyprexa related to its indication for use in adolescents (ages 13-17) for treatment of schizophrenia and bipolar I disorder [manic or mixed episodes]. The revised labeling states that:
• Section 1, Indications and Usage: When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia. Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents.
• Section 17.14, Need for comprehensive Treatment Program in Pediatric Patients: Zyprexa is indicated as an integral part of a total treatment program for pediatric patients with schizophrenia and bipolar disorder that may include other measures (psychological, educational, social) for patients with the disorder. Effectiveness and safety of ZYPREXA have not been established in pediatric patients less than 13 years of age.
Read the complete MedWatch 2010 Safety summary, including links to the Dear Healthcare Professional letter and revised Prescribing Information, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198402.htm | 1/29/2010 11:05 AM | Shujin | | | Edwards Lifesciences Aquarius Hemodialysis System: Recall | Edwards Lifesciences Aquarius Hemodialysis System: Recall
Audience: Nephrology and hemodialysis healthcare professionals, hospital risk managers
FDA and Edwards Lifesciences notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm. This could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death. The recall includes model numbers: GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. The product was distributed from July 12, 2007 through March 18, 2009. Baxter International, Inc. is the U.S. distributor of the Aquarius. The company notified its customers of a planned software upgrade to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period. Read the complete MedWatch 2010 Safety summary, including a link to the FDA recall notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199203.htm | 1/28/2010 10:45 PM | Shujin | | | Hettich Centrifuges: Recall | Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall
Audience: Hospital risk managers, Laboratory managers
FDA notified healthcare professionals of a Class I recall of Hettich Centrifuges with 2050 and 2076 plastic rotors, used in combination with the Mikro 12-24, Mikro 20, Haematokrit 20 and Haematokrit 24 bench top plastic centrifuges. The recall was initiated because the plastic centrifuge rotor may crack, break apart and be forcefully ejected through the plastic centrifuge housing at a high rate of speed. This may result in serious personal injury and damage to the surrounding area. The device separates the red blood cells from plasma to determine the patient’s hematocrit. These recalled devices were distributed from January, 1999 through November, 2009. Hospitals, clinics and laboratories who have the listed centrifuge/rotor combination should immediately stop using the plastic rotors and contact Hettich to have these affected rotors replaced with metal rotors. The centrifuges can be identified by reading the model number on the front of the instrument or the name tag on the rear of the centrifuge; the rotors have the model numbers 2076 or 2050 stamped on them. Read the complete MedWatch 2010 Safety summary, including a link to the FDA recall and firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199202.htm | 1/28/2010 10:40 PM | Shujin | | | Velcade (bortezomib) | Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment
Audience: Hematology, Oncology healthcare professionals
Takeda Oncology and FDA notified healthcare professionals about revisions to the Prescribing Information for Velcade, section 2.5, pertaining to patients with hepatic impairment at the start of Velcade therapy. The changes also include new safety information on dose adjustment for patients with moderate to severe hepatic impairment in label Section 5.11, stating: "Bortezomib is metabolized by liver enzymes. Bortezomib exposure is increased in patients with moderate or severe hepatic impairment; these patients should be treated with VELCADE at reduced starting doses and closely monitored for toxicities." Velcade is indicated for the treatment of patients with multiple myeloma. Velcade also is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Read the complete MedWatch 2010 Safety Summary, including a link to the Dear Healthcare Professional letter and revised Prescribing Information, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198424.htm | 1/26/2010 4:45 PM | Shujin | | | Infusion Set Needles: Recall | Infusion Set Needles [Manufactured by Nipro for Exelint]: Recall
Exel/Exelint Huber needles,
Exel/Exelint Huber Infusion Sets
Exel/Exelint “Securetouch+” Safety Huber Infusion Sets
Audience: Hospital Risk Managers, Surgical Service personnel
FDA notified healthcare professionals of a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation due to 'coring', the cutting or dislodging of silicone cores or slivers from the ports into which they are inserted. Huber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins for the withdrawal of blood and infusion of medication, nutritional solutions, blood products, and imaging solutions. Inspections conducted in October 2009 of Nipro facilities found that their needles “cored” in 60 to 72 percent of tests. The reason for this coring is related to design and manufacturing processes, which the FDA continues to investigate and will update the public if there are new developments. Hospitals, clinics and patients who have needles from these lists should immediately stop using these affected products and return any unused products to Exelint International Corporation. There are more than 2 million units impacted by this recall in distribution nationwide. Recalled needles were manufactured from January 2007 to August 2009. Units subject to recall have a lot number that begins with “07,” “08,” “09,” and one of the product codes or catalog numbers noted in the FDA news release. Read the complete MedWatch 2010 Safety summary, including a link to the FDA News Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198728.htm | 1/26/2010 4:45 PM | Shujin | | | Alli 60 mg capsules (120 count refill kit): Counterfeit Product | Alli 60 mg capsules (120 count refill kit): Counterfeit Product
Audience: Consumers, Pharmacy healthcare professionals
[UPDATE 01/23/2010] FDA updated January 18 alert with information on laboratory analysis of sibutramine levels in counterfeit product. Additional FDA laboratory tests on the counterfeit product show that people may be taking 3-times the usual daily dose (or twice the recommended maximum dose) of sibutramine if they are following the dosing directions for Alli. Healthy people who take this much sibutramine can experience anxiety, nausea, heart palpitations, tachycardia (a racing heart), insomnia, and small increases in blood pressure. This excessive amount of sibutramine is dangerous to people who have a history of cardiovascular disease, and can lead to elevated blood pressure, stroke, or heart attack. Read the MedWatch 2010 Safety summary including a link to both the original January 18 alert and the Update, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm197862.htm | 1/23/2010 5:05 PM | Shujin | | | Nipro GlucoPro Insulin Syringes: Recall | Nipro GlucoPro Insulin Syringes: Recall
Audience: Pharmacists, diabetes healthcare professionals, consumers
Nipro Medical Corporation and FDA notified healthcare professionals of a voluntary nationwide recall of all GlucoPro Insulin Syringes. These syringes may have needles that detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection. This recall includes all product codes and lot numbers with expiration dates before 2011-11 (November 1, 2011). Product was distributed nationwide, including Puerto Rico. Consumers who have GlucoPro Insulin Syringes should stop using and return them to point of sale for reimbursement. Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198445.htm | 1/22/2010 5:50 PM | Shujin | | | Meridia (sibutramine hydrochloride) |
Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review
Audience: Cardiology and endocrinology healthcare professionals
FDA notified healthcare professionals that the review of additional data indicates an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using sibutramine. Based on the serious nature of the review findings, FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label stating that sibutramine is not to be used in patients with a history of cardiovascular disease, including:
• History of coronary artery disease (e.g., heart attack, angina)
• History of stroke or transient ischemic attack (TIA)
• History of heart arrhythmias
• History of congestive heart failure
• History of peripheral arterial disease
• Uncontrolled hypertension (e.g., > 145/90 mmHg) Patients currently using sibutramine should talk with their healthcare professional to determine if continued use of sibutramine is appropriate and discuss any questions they may have about their treatment. Read the complete MedWatch 2010 Safety summary, including a link to the FDA Follow-up Communication and the original November 2009 MedWatch alert, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198221.htm | 1/21/2010 12:40 PM | Shujin | | | Alli 60 mg capsules (120 count refill kit): Counterfeit Product | Alli 60 mg capsules (120 count refill kit): Counterfeit Product
Audience: Consumers, Pharmacy healthcare professionals
FDA notified consumers and healthcare professionals about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit). The counterfeit version contained the controlled substance sibutramine and did not contain orlistat, the active ingredient. Sibutramine is a drug that should not be used in certain patient populations or without physician oversight. Sibutramine can also interact in a harmful way with other medications the consumer may be taking. GSK has determined that the counterfeit product has been sold over the internet. However, there is no evidence at this time that the counterfeit Alli product has been sold through other channels, such as retail stores. The differences between the counterfeit and authentic products are described in both text and photos in the FDA news release. Consumers who believe they have received counterfeit Alli are asked to contact the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI). Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178]. Read the complete MedWatch 2010 Safety summary, including a link to the FDA news release with photographs and description of differences between the authentic and counterfeit product, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm197862.htm | 1/18/2010 12:30 PM | Shujin | | | MuscleMaster(dot)com Products | MuscleMaster(dot)com Products Sold on Internet as Dietary Supplements: Recall
Audience: Consumers
MuscleMaster(dot)com, Inc. and FDA notified consumers and healthcare professionals of the voluntary nationwide recall of all lots and expiration dates of the seventeen dietary supplements listed in the firm press release, sold between June 1, 2009 and November 17, 2009. FDA informed MuscleMaster(dot)com that it believes that the recalled products contain ingredients that are steroids. FDA is concerned the products may present a safety risk to consumers who ingest them. Acute liver injury is known to be a possible harmful effect of using steroid-containing products. In addition, steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death. Customers who have these products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to using one or more of the products. Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178]. Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm197834.htm | 1/18/2010 12:25 PM | Shujin |  | | H1N1 Letter from Dr. Margaret Hamburg, Commissioner of Food and Drugs | Please find attached a follow-up communication on the November 10, 2009 Dear Healthcare Professional letter from Dr. Margaret Hamburg, Commissioner of Food and Drugs. The letter updates the FDA/CDC experience with the H1N1 vaccination program and provides some detail on the current vaccine safety monitoring program.We hope this information will be helpful to you as you manage and care for your patients during this influenza season. The letter can also be viewed on FDA’s H1N1 website at http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm197733.htm | 1/18/2010 12:20 PM | Shujin | | | McNeil Consumer Healthcare Over-The-Counter Products: Recall |
McNeil Consumer Healthcare Over-The-Counter Products: Recall
Audience: Consumers, Pharmacists [Posted 01/15/2010] McNeil and FDA notified healthcare professionals of an expansion of the December 2009 recall. McNeil Consumer Healthcare has now applied broader criteria to identify and remove all product lots that it believes may have the potential to be affected, even if they have not been the subject of consumer complaints. Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. The affected product lot numbers for the recalled products can be found on the side of the bottle label. Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at: www.fda.gov/medwatch. Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm197740.htm/ucm197740.htm | 1/18/2010 12:15 PM | Shujin | | | HAPPYTOT Stage 4 and HAPPYBABY Stage 1 & Stage 2 Pouch Meals – Recall | HAPPYTOT Stage 4 and HAPPYBABY Stage 1 & Stage 2 Pouch Meals – Recall
Audience: Consumers, pediatric healthcare professionals and dieticians
FDA notified healthcare professionals that Nurture, Inc., is recalling selected varieties and date codes of HAPPYTOT Stage 4 and HAPPYBABY Stage 1 and Stage 2 pouch meals with date codes expiring between November 2010 and January 2011 due to a packaging defect that could cause a possible bacterial contamination. The meals are packaged in plastic pouches with plastic caps. Recalled varieties and UPC codes are listed in the firm's press release. Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm197570.htm | 1/13/2010 8:10 PM | Shujin | | | Rapamune (sirolimus) | Rapamune (sirolimus): Drug Monitoring Recommendations
Audience: Transplantation and nephrology healthcare professionals, hospital laboratory directors
Wyeth notified healthcare professionals of changes to the Rapamune Prescribing Information regarding changes in the performance of an immunoassay used for therapeutic drug monitoring (TDM) of sirolimus. The TDM results reported from the assay are both assay and laboratory-dependent. In addition, the results may change over time. Therefore, adjustment to the targeted therapeutic range must be made with a detailed knowledge of the site-specific assay used. Sirolimus whole blood concentrations can be measured by either chromatographic or immunoassay methodologies. These two methodologies are not directly interchangeable and the measured sirolimus whole blood concentrations depend on the type of assay used. As such, if different assays are used in monitoring a single patient, the dose of Rapamune might be adjusted improperly with potential consequences, such as allograft rejection if drug exposure is too low or toxic side effects if exposure is too high. Wyeth has advised healthcare providers involved in the management of patients taking Rapamune to determine: 1) which assay is being used in their laboratory(ies); 2) if there is any change to the assay used; 3) if there is a change to the laboratory’s reference range and/or a subsequent change to the institution’s or referring center’s recommended range for sirolimus. With this information, target levels can be appropriately adjusted in order to achieve optimal clinical results. It is critical that the clinician caring for a patient on sirolimus maintain communication with their laboratory to determine whether the assay used for measuring sirolimus concentrations has been changed. Read the complete MedWatch 2010 Safety summary, including a link to the Wyeth Dear Healthcare Professional letter, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm197059.htm | 1/11/2010 6:05 PM | Shujin | | | Trailblazer Support Catheter | ev3 Endovascular Inc. Trailblazer Support Catheter: Device may crack near the radiopaque marker band, potentially resulting in serious patient injury
Audience: Vascular healthcare professionals, hospital risk managers
[Posted 01/05/2010] ev3 Endovascular, Inc. and FDA notified healthcare professionals of a Class I Recall of the Trailblazer Support Catheter. This device may crack near the radiopaque marker band. This may result in serious patient injury, including insufficient oxygen supply to the tissues, damage to blood vessels, heart attack, limb amputation, unplanned surgery, and/or death. See the Recall Notice for a listing of affected model and lot numbers, manufactured from September 11, 2009 through September 29, 2009 and distributed from September 21, 2009 through October 27, 2009. Read the MedWatch safety summary, including a link to the Recall Notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm196266.htm | 1/5/2010 5:40 PM | Shujin | | | Nzu, Traditional Remedy for Morning Sickness | Nzu, Traditional Remedy for Morning Sickness Audience: Consumers, Obstetrical healthcare professionals The Texas Department of State Health Services and FDA notified healthcare professionals and consumers, especially pregnant or breastfeeding women, to avoid consuming a product called “Nzu”, taken as a traditional remedy for morning sickness,because of the potential health risks from high levels of lead and arsenic, noted on laboratory analysis by Texas DSHS. Exposure to lead can result in a number of harmful effects, and a developing child is particularly at risk of effects on the brain and nervous system. Arsenic is a carcinogen, and excessive long-term exposure to it has been associated with a range of adverse health effects, including cancers of the urinary bladder, lung and skin. Nzu, which is sold at African specialty stores is also called Calabash clay, Calabar stone, Mabele, Argile and La Craie. It generally resembles balls of clay or mud and is usually sold in small plastic bags with a handwritten label identifying it as “Nzu” or “Salted Nzu.” Anyone who has been ingesting the product should contact their health care provider. Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178]. Read the complete MedWatch 2009 Safety summary, including a link to the Texas State Health Services press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm196045.htm | 1/1/2010 12:40 AM | Shujin | | | Tylenol Arthritis Pain Caplet 100 count: Recall | Tylenol Arthritis Pain Caplet 100 count: Recall of all lots Audience: Consumers, Pharmacists McNeil Consumer Healthcare and FDA notified consumers that it is expanding a voluntary recall to include all available product lots of TYLENOL Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP (Full list of lot numbers provided in press release at link below). In November 2009, 5 lots of this product were recalled due to consumer reports of an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. The odor is caused by the presence of a chemical 2,4,6-tribromoanisole, believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this compound have not been well studied, and to date all of the observed events reported to McNeil were temporary and non-serious. Consumers who purchased TYLENOL Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-OPEN CAP from the lots included in this recall should stop using the product and contact McNeil for instructions on a refund or replacement. Read the complete MedWatch 2009 Safety summary, including a link to the firm's press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm195704.htm | 12/31/2009 9:05 PM | Shujin | | | Thermoflect Blankets and product line – Recall | Thermoflect Blankets and product line – Recall Audience: Radiological healthcare professionals, hospital risk managers Encompass Group and FDA notified healthcare professionals of the voluntary recall of the Thermoflect product line for relabeling regarding its use in the MR (Magnetic Resonance) environment. FDA has recommended that the Thermoflect blankets and other products not be used in MR conditional or MR compatible environments. Encompass is in the process of sending labels to customers to be attached per instructions to remind hospitals that the product line should not be used in the MR environment. A complete list of Thermoflect products and additional information can be found at www.thermoflect.com. Read the complete MedWatch 2009 Safety summary, including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm195703.htm | 12/31/2009 7:00 PM | Shujin | | | Cleviprex (clevidipine butyrate): Recall | Cleviprex (clevidipine butyrate): Recall
Audience: Pharmacists, risk managers
The Medicines Company and FDA notified healthcare professionals of a nationwide recall of eleven lots of Cleviprex (clevidipine butyrate) injectable emulsion, indicated for treatment of hypertension, due to the potential presence of particulate matter found to be inert stainless steel particles. If the particles were to aggregate, or if larger particles were present, then they could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions. Reduced blood supply to tissues may lead to ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs. See the company press release for information on specific lots affected by this recall. Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178]. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm194585.htm | 12/17/2009 3:00 PM | Shujin | | | Atlas Operations, Inc.: Recall of Sexual Enhancement Products | Atlas Operations, Inc.: Recall of Sexual Enhancement Products
Audience: Consumers
Atlas Operations, Inc. and FDA notified consumers of a nationwide recall of the company's dietary supplements for sexual enhancement. These products are currently being sold as dietary supplements throughout the United States. FDA lab analyses found that the products tested from certain batches contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male erectile dysfunction, making these products unapproved drugs. The active drug ingredient is not listed on the product labels. The undeclared ingredient may pose a threat to the consumer because the interaction of the analogue with some prescription drugs (such as nitroglycerin) may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take other prescription drugs. Erectile Dysfunction is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance. Read the company Press Release for a complete list of product names and lot numbers. The FDA advises consumers who have experienced any adverse events from sexual enhancement products to consult a health care professional. Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178]. Read the complete MedWatch 2009 Safety summary, including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm194091.htm | 12/15/2009 11:05 PM | Shujin | | | Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels |
Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging
Audience: Consumers
[Posted 12/09/2009] Bayer Consumer Care and FDA notified Consumers of a recall of a single product lot of the combination package of Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels. The labeling on the foil blister card of certain packages within the lot were printed with the label reversed. The label for the green Night product appears under some of the blue Day product and vice versa. Consumers using the affected product lot may not be aware of the warnings of an antihistamine in the product that could cause drowsiness. The affected Alka-Seltzer Plus product lot number can be found on both the interior blister package (in black text adjacent to the expiration date) as well as on the exterior carton containing the blister packaging (embossed on the side panel under the Bayer logo). This product was sold only in the U.S. at retail outlets nationwide.
· Package size: 20 liquid filled capsules per carton (12 day formulation capsules and 8 night formulation capsules)
- UPC#: 016500537779
- Lot #: 296939L
- Expiration: 5/11
Consumers who purchased combination packages of Alka-Seltzer Plus Day and Night Cold Formula Liquid Gels from the lot included in this recall should stop using the product and contact Bayer with any questions or for instructions on a refund or replacement. See the company Press Release for contact information. Read the MedWatch safety summary, including a link to the Bayer Consumer Care Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm193583.htm | 12/10/2009 11:50 AM | Shujin | | | CT Brain Perfusion Scans |
CT Brain Perfusion Scans Safety Investigation - Additional cases of excess radiation exposure, recommendations provided
Audience: Radiological, Neurological and emergency medicine healthcare professionals
[UPDATED 12/07/2009] The FDA, working with state and local health authorities, has identified at least 50 additional patients who were exposed to excess radiation of up to eight times the expected level during their CT perfusion scans. These cases so far involve more than one manufacturer of CT scanners. Some of these patients reported hair loss or skin redness following their scans. High doses of radiation can cause cataracts and increase the risk of some forms of cancer. On the basis of its investigation to date, the FDA is providing interim recommendations for imaging facilities, radiologists, and radiologic technologists to help prevent additional cases of excess exposure.
These recommendations include:Facilities assess whether patients who underwent CT perfusion scans received excess radiation.
- Facilities review their radiation dosing protocols for all CT perfusion studies to ensure that the correct dosing is planned for each study.
- Facilities implement quality control procedures to ensure that dosing protocols are followed every time and the planned amount of radiation is administered.
- Radiologic technologists check the CT scanner display panel before performing a study to make sure the amount of radiation to be delivered is at the appropriate level for the individual patient.
- If more than one study is performed on a patient during one imaging session, practitioners should adjust the dose of radiation so it is appropriate for each study.
Read the MedWatch safety summary, including a link to the FDA News Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186105.htm | 12/8/2009 12:20 PM | Shujin | | | Voltaren Gel | Voltaren Gel (diclofenac sodium topical gel) 1% - Hepatic Effects Labeling Changes
Audience: Rheumatological healthcare professionals, pharmacists
Endo, Novartis and FDA notified healthcare professionals of revisions to the Hepatic Effects section of the Prescribing Information to add new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium. In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation. Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac. The optimum times for making the first and subsequent transaminase measurement are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac. Read the complete MedWatch 2009 Safety summary, including links to the Dear Healthcare Professional letter and revised Prescribing Information, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm193047.htm | 12/5/2009 1:40 AM | Shujin | | | Slim Fast ready-to-drinks recalled | All Slim-Fast ready-to-drink canned products are being recalled because they may be contaminated with a bacterium called Bacillus cereus. It can cause diarrhea, nausea, and/or vomiting.
| 12/4/2009 5:05 PM | Shujin | | | Steris System 1 Processor | Steris System 1 Processor: FDA Notice and Recommendations
Audience: Hospital risk managers, surgical service managers, infection control professionals
FDA notified healthcare facility administrators and infection control healthcare professionals of important information regarding the regulatory status of the STERIS System 1 Processor (SS1) used in surgical and endoscopy suites for reprocessing, i.e., sterilizing or disinfecting, medical devices. STERIS has significantly modified the SS1 and FDA has not approved or cleared this modified product. Thus, FDA has not determined whether the SS1 is safe or effective for its labeled claims, including claims that it sterilizes medical devices. Use of a device that is promoted to sterilize or disinfect a medical or surgical device, but that does not properly perform these functions, poses risks to patients and users. Improperly disinfected or sterilized instruments may transmit pathogens to patients and healthcare staff, or expose them to hazardous chemicals. Improper sterilization or disinfection may also adversely affect the quality and functionality of reprocessed instruments. FDA has received some reports of malfunctions of the SS1 that had the potential to cause or contribute to serious injuries to patients, such as infections. There have also been reports of injuries, mostly burns from exposure to the sterilant solution, to healthcare facility staff operating the device. FDA recommends that if a facility has an acceptable alternative to the SS1 to meet sterilization and disinfection needs, the facility should transition to that alternative as soon as possible to ensure continued patient safety. If an acceptable alternative to the SS1 is not available, the facility should promptly assess its patient-care needs and sterilization and disinfection requirements and take steps to obtain legally-marketed substitutes for the SS1. User facilities, including hospitals, are required to report suspected device-related deaths to FDA and the manufacturer, and serious injuries to the manufacturer or to FDA, if the manufacturer is unknown (see http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/PostmarketRequirements/ ReportingAdverseEvents/default.htm). Also, FDA solicits voluntary reports of adverse events from healthcare professionals. Adverse events may be submitted online. Read the complete MedWatch 2009 Safety summary, including a link to the FDA letter to healthcare facilities, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192842.htm | 12/3/2009 10:40 PM | Shujin | | | Valproate Sodium and related products (valproic acid and divalproex sodium) | Valproate Sodium and related products (valproic acid and divalproex sodium): Risk of Birth Defects
Audience: Neurological and Obstetrical healthcare professionals
The FDA notified health care professionals and patients about the increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies exposed to valproate sodium and related products (valproic acid and divalproex sodium) during pregnancy. Healthcare practitioners should inform women of childbearing potential about these risks, and consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening. Women of childbearing potential should only use valproate if it is essential to manage their medical condition. Those who are not actively planning a pregnancy should use effective contraception, as birth defect risks are particularly high during the first trimester, before many women know they are pregnant. A valproate Medication Guide, provided with each outpatient prescription, will explain the benefits and risks of valproate and encourage patients to discuss options with their healthcare professional. Pregnant women using valproate or other AEDs should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry (1-888-233-2334; www.aedpregnancyregistry.org). Read the complete MedWatch 2009 Safety summary, including a link to the Information for Health Professionals sheet, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192788.htm | 12/3/2009 4:10 PM | Shujin | | | Lexiva (fosamprenavir calcium) | Lexiva (fosamprenavir calcium)
Audience: HIV/Infectious Disease healthcare professionals, cardiovascular healthcare professionals
GlaxoSmithKline and FDA notified healthcare professionals of a potential association between Lexiva and myocardial infarction and dyslipidemia in HIV infected adults. GSK has modified the existing Warnings and Precautions section of the Prescribing Information to note that increases in cholesterol have occurred with treatment, the importance of lipids management, and a recommendation that triglyceride and cholesterol testing be performed prior to initiating therapy with LEXIVA and at periodic intervals during therapy. The Dear Healthcare Professional letter also provides key messages, actions required by healthcare professionals and supporting information from a case-control study reported at a February 2009 international HIV conference. Read the complete MedWatch 2009 Safety summary, including a link to the Dear Healthcare Professional letter, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192699.htm | 12/3/2009 2:35 PM | Shujin | | | Norpramin (desipramine hydrochloride) | Norpramin (desipramine hydrochloride)
Audience: Psychiatric healthcare professionals
Sanofi-Aventis and FDA notified healthcare professionals of changes to the Warnings and Overdosage sections of the Prescribing Information for Norpramin (desipramine hydrochloride), indicated for the treatment of depression. The new safety information states that extreme caution should be used when this drug is given to patients who have a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances; and that seizures precede cardiac dysrhythmias and death in some patients. Read the complete MedWatch 2009 Safety summary, including a link to the Dear Healthcare Professional letter, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192655.htm | 12/2/2009 4:00 PM | Shujin | | | Stryker Operating Room System II Surgical Navigation System – Recall | Stryker Operating Room System II Surgical Navigation System – Recall
Audience: Hospital risk managers, surgical service managers
Stryker and FDA notified healthcare professionals of a recall of 23 Operating Room System II Surgical Navigation Systems because there is a potential for the navigation PC SPC-1 component to stop working which could result in the screen freezing, the system updating at a slow rate, or not responding at all. The Navigation System II is a computer aided surgery platform that surgeons can use to perform Hip, Knee, Spine, Neuro and ENT surgical procedures and contains a computer workstation with the navigation System II software and various components necessary to run the system.The potential harms associated with this failure are: delay in surgery, reschedule of the procedure resulting in an additional surgery, risk of infection, increased morbidity, potential neurological deficits, or injury due to the surgeon operating in an area where they did not intend to operate. Depending on the type of surgery, these failures could potentially lead to serious adverse health consequences, including death. Hospitals that have product that corresponds to the catalog numbers above should immediately quarantine the product, label it as a recalled product and stop using the product. Read the complete MedWatch 2009 Safety summary including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192105.htm | 11/27/2009 5:30 PM | Shujin | | | Meridia (sibutramine) | Meridia (sibutramine)
Audience: Cardiology and endocrinology healthcare professionals
FDA notified healthcare professionals and patients that it is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than patients using a placebo (sugar pill). Sibutramine is marketed as Meridia, a prescription drug, in the United States. Meridia was approved by FDA in 1997 for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with a reduced calorie diet. Meridia is only recommended for obese patients with an initial body mass index (BMI) ≥ 30 kg/m2, or BMI ≥ 27 kg/m2 with other risk factors (e.g., diabetes, high cholesterol, controlled high blood pressure).The analysis of these data is ongoing and FDA is making no conclusions about the preliminary findings at this time. These findings highlight the importance of avoiding the use of sibutramine in patients with a history of coronary artery disease (heart disease), congestive heart failure (CHF), arrhythmias, or stroke, as recommended in the current sibutramine labeling. Read the MedWatch safety summary, including a link to the FDA Early Communication about an Ongoing Safety Review, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191655.htm | 11/21/2009 7:40 PM | Shujin | | | Cardiac Science Corp. Powerheart and CardioVive | Cardiac Science Corp. Powerheart and CardioVive Automated External Defibrillators: Initial Communication
Audience: Cardiology healthcare professionals, hospital risk managers, biomedical engineering staff, emergency responders
Cardiac Science Corporation has received multiple complaints related to defective components in these AEDs that indicate the affected devices may not deliver electric shocks and that the devices’ self-test may not detect the defect in advance of their use. 300,000 Cardiac Science AEDs worldwide are potentially affected by this problem. The G3 Series devices were manufactured between August 2003 and August 2009. Affected models include the following:
• Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E; and
• CardioVive 92531, 92532 , and 9253
Because the AED display screen and/or audible indicators may not accurately indicate whether the device is functioning properly or will function properly at time of use, FDA encourages users of the affected AEDs to follow the additional precautions provided in this communication. FDA is gathering more data about this situation to better understand its potential public health impact and will make available any new information that might affect the use of these AED devices. Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical devices. FDA encourages anyone who suspects any electronic or mechanical problem(s) with an AED to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Read the complete MedWatch 2009 Safety summary, including a link to the FDA Initial Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191471.htm | 11/20/2009 12:25 AM | Shujin | | | Vicks Sinex Nasal Spray – Recall | Vicks Sinex Nasal Spray – Recall
Audience: Consumers
Procter & Gamble and FDA notified consumers of a voluntary recall of three lots of Vicks Sinex Nasal Spray in the United States, Germany and the United Kingdom. The bacteria B. cepacia was found in a small amount of product made at its plant in Gross Gerau, Germany. There have been no reports of illness. However, the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis. Consumers should simply discard the affected product as they would any over the counter medicine. Customers who have the affected lots can call P&G for a replacement coupon or refund. Read the complete MedWatch 2009 Safety summary, including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191413.htm | 11/20/2009 12:20 AM | Shujin | | | RockHard Weekend, marketed as dietary supplement | RockHard Weekend, marketed as dietary supplement, contains undeclared drug ingredient sulfoaildenafil
Audience: Consumers, pharmacists
[Posted 11/18/2009] RockHard Laboratories and FDA notified consumers that RockHard Weekend, a product sold as a dietary supplement, contains sulfoaildenafil, an analogue of sildenafil, an FDA-approved drug used as treatment for Erectile Dysfunction. The presence of sulfoaildenafil makes RockHard Weekend an unapproved drug. This undeclared drug ingredient may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. RockHard Weekend is sold nationwide in single blisters, 3-count and 8-count bottles. RockHard Laboratories advises any customers in possession of RockHard Weekend to return any unused product for a full refund to the company directly. Customers can call 1.800.562.0543 for instructions on the return and refund process. The FDA advises consumers who have experienced any adverse events from sexual enhancement products to consult a health care professional. Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178]. Read the MedWatch safety summary, including a link to the company Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191052.htm | 11/18/2009 10:40 AM | Shujin | | | Cardiovascular Systems ViperSheath Sheath Introducer - Nationwide recall | Cardiovascular Systems ViperSheath Sheath Introducer - Nationwide recall
Audience: Cardiological and interventional radiological healthcare professionals, hospital risk managers
Cardiovascular Systems, Inc. and FDA notified healthcare professionals of a nationwide recall of all lots of the ViperSheath Sheath Introducer on behalf of Thomas Medical due to reports about stretching or fracture of the sheath during use. In the event of a device fracture, separated segments of the device may require unplanned open surgery to remove the retained segments or control bleeding. Since this device is coil reinforced, any separation of the cannula (a flexible tube inserted into the body) has the potential to expose portions of the coil, creating the potential for vessel dissection or perforation. The recall encompasses products distributed from March 25, 2009 to October 21, 2009, and includes the following lot ranges and catalog numbers:
• Lot range: S28117 through S29174
• Catalog numbers: VPR-ISH 5 X 85, VPR-ISH 6 X 85, VPR-ISH 7 X 85, VPR-ISH 5 X 45, VPR-ISH 6 X 45, VPR-ISH 7 X 45
Read the MedWatch safety summary, including a link to the company's Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190967.htm | 11/18/2009 1:25 AM | Shujin | | | IDS Sports Dietary Supplements - Five products recalled | Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec)
Audience: Consumers
[Posted 11/17/2009] IDS Sports and FDA notified consumers that five of the IDS's dietary supplement products (Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR) contain the following undeclared substances, which FDA considers to be steroids: “Madol,” “Turinabol,” “Superdrol,” and/or “Androstenedione.”Acute liver injury is known to be a possible harmful effect of using steroid-containing products. In addition, steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death. The recalled products were distributed in either black boxes containing blister packs of 60 capsules or white bottles with black labels containing 30 or 60 capsules. Customers who have any of the products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to using the products. Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178]. Read the MedWatch safety summary, including a link to the Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190925.htm | 11/18/2009 1:20 AM | Shujin | | | Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec) | Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec)
Audience: Cardiovascular healthcare professionals, pharmacists
[Posted 11/17/2009] FDA notified healthcare professionals of new safety information concerning an interaction between clopidogrel (Plavix), an anti-clotting medication, and omeprazole (Prilosec/Prilosec OTC), a proton pump inhibitor (PPI) used to reduce stomach acid. New data show that when clopidogrel and omeprazole are taken together, the effectiveness of clopidogrel is reduced. Patients at risk for heart attacks or strokes who use clopidogrel to prevent blood clots will not get the full effect of this medicine if they are also taking omeprazole. Separating the dose of clopidogrel and omeprazole in time will not reduce this drug interaction. Other drugs that are expected to have a similar effect and should be avoided in combination with clopidogrel include: cimetidine, fluconazole, ketoconazole, voriconazole, etravirine, felbamate, fluoxetine, fluvoxamine, and ticlopidine. Recommendations for healthcare professionals are provided in the "Information for Healthcare Professionals" sheet. Read the MedWatch safety summary, including links to the FDA Information for Healthcare Professionals sheet, Public Health Advisory, and Follow-up to the January 26, 2009 Early Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190848.htm | 11/18/2009 1:10 AM | Shujin | | | Negative Pressure Wound Therapy (NPWT) systems | Negative Pressure Wound Therapy (NPWT) systems - Preliminary Public Health Notification
Audience: Acute and long-term healthcare facilities staff, consumers
[Posted 11/16/2009] FDA notified healthcare professionals of a Preliminary Public Health Notification describing deaths and serious complications associated with the use of Negative Pressure Wound Therapy (NPWT) systems. FDA has received reports of six deaths and 77 injuries associated with NPWT systems over the past two years. NPWT systems are generally indicated for the management of wounds, burns, ulcers, flaps and grafts. They apply negative pressure to the wound in order to remove fluids, including wound exudates, irrigation fluids, and infectious materials. Healthcare professionals were advised to select patients for NPWT carefully, after reviewing the most recent device labeling and instructions. Patients should be monitored frequently in an appropriate care setting by a trained practitioner, and practitioners should be vigilant for potentially life-threatening complications, such as bleeding, and be prepared to take prompt action if they occur. Read the MedWatch safety summary, including links to the FDA Preliminary Public Health Notification and FDA Advice to Patients, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190704.htm | 11/16/2009 11:35 PM | Shujin | | | Chondrolysis - bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, ropivacaine | Local Anesthetics, Continuously Infused (marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, ropivacaine) – Chondrolysis
Audience: Orthopedic and Anesthesia healthcare professionals, hospital risk managers
FDA notified healthcare professionals of 35 reports of chondrolysis (necrosis and destruction of cartilage) in patients given continuous intra-articular infusions of local anesthetics with elastomeric infusion devices to control post-surgical pain. The local anesthetics (with and without epinephrine) were infused for extended periods of time (48 to 72 hours) directly into the intra-articular space using an elastomeric pump. Joint pain, stiffness, and loss of motion were reported as early as the second month after receiving the infusion. In more than half of these reports, the patients required additional surgery, including arthroscopy or arthroplasty (joint replacement). Local anesthetics are approved as injections for the production of local or regional anesthesia or analgesia. The approved drug labels for local anesthetics do not include an indication for continuous intra-articular postoperative infusions or use of infusion devices, such as elastomeric pumps. The FDA has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics. Health care professionals are encouraged to follow the instructions for use of elastomeric infusion devices, and to not use these devices for continuous intra-articular infusion of local anesthetics after orthopedic surgery. This notice provides further management considerations for healthcare professionals, information for patients, a data summary of the 35 reports, and references. Read the complete MedWatch 2009 Safety summary, including a link to the Information for Healthcare Professionals sheet, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190496.htm | 11/13/2009 4:55 PM | Shujin | | | Pai You Guo, Marketed as Dietary Supplement – Recall | Pai You Guo, Marketed as Dietary Supplement – Recall
Audience: Consumers
GMP Herbal Products and FDA notified consumers and healthcare professionals of a recall of Pai You Guo, a weight loss dietary supplement, due to the presence of undeclared drug ingredients. FDA lab analyses of dietary supplements were found to contain undeclared sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss; and phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States. The FDA has not approved the Pai You Guo products as a drug; therefore the safety and effectiveness of this product is unknown. The product is sold either in a box of 30 capsules or a bag of 10 g powder. The affected products were sold and distributed nationwide via the internet. FDA advises that these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Consumers are advised to destroy the affected products or return them to the company’s address in Westminster, CA. Read the complete MedWatch 2009 Safety summary, including a link to the firm press release at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190531.htm | 11/13/2009 4:50 PM | Shujin | | | Cerezyme, Fabrayzme, Myozyme, Aldurazyme, and Thyrogen | Genzyme Products, Marketed as Cerezyme, Fabrayzme, Myozyme, Aldurazyme, and Thyrogen
Audience: Endocrinological and Genetics Medicine healthcare professionals
FDA and Genzyme notified healthcare professionals about the potential for foreign particle contamination of several products that are used to treat rare, serious, and life-threatening diseases. The foreign particles include stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process and could potentially cause serious adverse events in patients. Cerezyme, Fabrazyme, Myozyme, and Thyrogen are supplied as lyophilized powders requiring reconstitution before administration; Aldurazyme is supplied as a liquid solution. Potential adverse events from IM administration of a contaminated product could include local pain, swelling and inflammation. Potential adverse reactions from IV administration of a product contaminated with foreign particles could be more serious, including damage to blood vessels or embolic events, and anaphylactic, allergic and immune-mediated reactions. It is also possible that the foreign particles could affect how well these products work. The Agency is acutely aware of the critical need for patients to have continued access to these important products. In reaching its decision to allow these products to continue to be marketed, FDA has carefully considered the potential for serious adverse events, the likelihood that the recommendations in this notice will significantly reduce the risk of administration of contaminated products, and the lack of FDA-approved therapeutic alternatives for these products. The FDA is actively investigating the nature of the contamination and seeking immediate implementation of corrective actions to mitigate the situation. Read the complete MedWatch 2009 Safety summary, including a link to the Information for Healthcare Professionals sheet, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190480.htm | 11/13/2009 3:05 PM | Shujin | | | Synthes USA, Ti Synex II Vertebral Body Replacement - Class I Recall | Synthes USA, Ti Synex II Vertebral Body Replacement - Class I Recall
Audience: Orthopedic and neurological healthcare professionals, hospital risk managers
[Posted 11/12/2009] FDA notified healthcare professionals of a Class I Recall of all lots of the Synthes USA, Ti Synex II Vertebral Body Replacement, a device used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body. Reports of moderate to severe loss of vertebral body replacement height (caused by failure of the central body component) in situ at six to fifteen months post implantation were received. Potential adverse health issues that could be associated with this issue include neural injury, increased pain, spinal kyphosis if unrecognized, failure of supplementary fixation, and/or need for reoperation/revision surgery. Surgeons and hospitals in possession of the subject devices must stop implanting them immediately. This product was manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009. Read the complete MedWatch 2009 Safety summary, including a link to the Class 1 recall, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190330.htm | 11/12/2009 7:10 PM | Shujin | | | External Biphasic Defibrillators Energy Levels | External Biphasic Defibrillators Energy Levels: Initial Communication
Audience: Cardiology healthcare professionals, hospital risk managers and biomedical engineering staff
Devices: External biphasic defibrillators that deliver energy levels ≤ 200 Joules (J), including monitor/defibrillators and automated external defibrillators (AEDs).
[Posted 11/10/2009] FDA notified healthcare professionals that it is investigating energy levels in external biphasic defibrillators with shocks ≤ 200 J. FDA received reports of 14 events since 2006 in which a 200 J biphasic defibrillator was ineffective in providing defibrillation/cardioversion therapy to a patient, whereas a subsequent shock from a different 360 J biphasic defibrillator resulted in immediate defibrillation/cardioversion. The majority of events occurred during attempts at cardioversion of atrial fibrillation, but there was at least one instance with defibrillation of a ventricular arrhythmia as well. Analysis of the 14 cases does not suggest the need for any change to current clinical practice, and as FDA continues its evaluation of this situation, providers are encouraged to follow the American Heart Association’s guidelines/algorithms for treatment of cardiac arrhythmias, and to follow manufacturers’ instructions for using defibrillators. FDA is seeking additional information in order to interpret the significance of these events, and to determine whether FDA activities are advised. If you suspect a problem with a defibrillator, such as a situation where a patient received shocks from multiple devices, the problem should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178]. Read the complete MedWatch 2009 Safety summary, including an link to the Initial Communication, at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm189259.htm | 11/10/2009 11:35 PM | Shujin | | | 2009 H1N1 influenza Letter from Comissioner of Food & Drugs |
Dear Healthcare Professional letter from Dr. Margaret Hamburg, Commissioner of Food and Drugs, thanking healthcare providers for their efforts during the 2009 H1N1 influenza outbreak. The letter also addresses questions of vaccine safety and availability. In the letter, Commissioner Hamburg outlines the processes that took the 2009 H1N1 influenza vaccine from creation to manufacture to distribution. We hope this information will be helpful to you when answering questions about the 2009 H1N1 influenza vaccines. The letter can also be viewed via FDA’s H1N1 website at http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm189691.htm | 11/10/2009 11:30 PM | Shujin | | | Edwards Lifesciences CardioVations EndoClamp Aortic Catheter - Class 1 Recall | Edwards Lifesciences CardioVations EndoClamp Aortic Catheter - Class 1 Recall
Audience: Cardiovascular healthcare professionals, hospital risk managers
FDA and Edwards Lifesciences notified healthcare professionals about the Class 1 recall of CardioVations EndoClamp Aortic Catheter, Model Numbers EC1001 and EC65, a device that blocks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures. The recall was initiated because the balloon catheters may spontaneously rupture during surgery. This product was manufactured from August, 2008 through August, 2009 and distributed from November, 2008 through September, 2009. Read the complete MedWatch 2009 Safety summary, including a link to the Class 1 recall notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm189650.htm | 11/9/2009 11:50 PM | Shujin | | | Hospira Brand Propofol and Liposyn Products – Recall | Hospira Brand Propofol and Liposyn Products – Recall
Audience: Anesthesiology and intensivist healthcare professionals, hospital risk managers
Hospira, Inc.and FDA notified healthcare professionals of the recall of 85 lots of Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, and Liposyn III 30%, and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80 because some of the containers may contain particulate matter. The source of the particulate matter has been identified as stainless steel equipment used in the manufacturing process. The affected lots were distributed between July 2009 and October 2009, and no other lots are affected by this recall. Since these particulate contaminants do not dissolve in blood they could potentially act as emboli and impede blood flow. Particulates may also cause mechanical damage to the body and may escalate damage through the Systemic Inflammatory Response Syndrome. Restriction in blood supply to tissues could lead to stroke, respiratory failure, kidney failure, liver failure, heart attack and/or death. Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178]. Read the complete MedWatch 2009 Safety summary, including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm189589.htm | 11/9/2009 11:45 PM | Shujin | | | Stiff Nights, marketed as dietary supplement | Stiff Nights, marketed as dietary supplement
Audience: Consumers, Pharmacists
[Posted 11/05/2009] FDA notified consumers that Stiff Nights, a product sold as a dietary supplement, contains sulfoaildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. Sulfoaildenafil may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. The product is distributed on Internet sites and at retail stores by Impulsaria LLC of Grand Rapids, Michigan. It is sold in bottles containing 6, 12, or 30 red capsules or in blister packs containing one or two capsules. The FDA advises consumers who have experienced any adverse events from sexual enhancement products to consult a health care professional. Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178]. Read the MedWatch safety summary, including a link to the FDA News Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm189300.htm | 11/5/2009 3:30 PM | Shujin | | | Centurion Medical Products Premie Pack and Meconium Pack Recall | Centurion Medical Products Premie Pack and Meconium Pack Recall
Audience: Anesthesiology healthcare professionals, hospital risk managers
Centurion Medical Products and FDA notified healthcare professionals about a Class I recall of Premie Pack, Kit Code LM 110 and Full Term Meconium Pack, Kit Code LM115. The pediatric tracheal tubes used in these kits were manufactured with an internal diameter smaller than indicated on the label, which could result in an inability to remove secretions and cause partial or complete blockage of the airway and the inability to ventilate the patient. These products were distributed from January 1, 2007 through September 22, 2009. Read the MedWatch safety summary, including a link to the FDA Class I Recall Notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188981.htm | 11/4/2009 11:45 AM | Shujin | | | Bodybuilding.com Brand Dietary Supplements | Bodybuilding.com Brand Dietary Supplements - Sold on Internet
Audience: Consumers
Bodybuilding.com and FDA notified healthcare professionals and patients of a nationwide and international recall of all lots and expiration dates of 65 dietary supplement products that were sold through the Company's website, www.bodybuilding.com. FDA believes that the recalled products contain the following ingredients that are currently classified, or the FDA believes should be classified, as steroids: "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol." Acute liver injury is known to be a possible harmful effect of using steroid-containing products. In addition, steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death. Customers who have any of the products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking one or more of the ingredients listed above. Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms" page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178]. Read the complete MedWatch 2009 Safety summary, including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188957.htm | 11/3/2009 10:55 PM | Shujin | | | Byetta (exenatide) - Renal Failure |
Byetta (exenatide) - Renal Failure
Audience: Endocrine and nephrology healthcare professionals
FDA notified healthcare professionals of revisions to the prescribing information for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency. Byetta, an incretin-mimetic, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. From April 2005 through October 2008, FDA received 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency), in patients using Byetta. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems. Labeling changes include:
· Information regarding post-market reports of acute renal failure and insufficiency, highlighting that Byetta should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease.
· Recommendations to healthcare professionals that caution should be applied when initiating or increasing doses of Byetta from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/min).
· Recommendations that healthcare professionals monitor patients carefully for the development of kidney dysfunction, and evaluate the continued need for Byetta if kidney dysfunction is suspected while using the product.
· Information about kidney dysfunction in the patient Medication Guide to help patients understand the benefits and potential risks associated with Byetta. Read the complete MedWatch 2009 safety summary, including a link to the Healthcare Professional information sheet, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188703.htm | 11/2/2009 5:50 PM | Shujin | | | Pointe Scientific Liquid Glucose Hexokinase Reagent – Recall | Pointe Scientific Liquid Glucose Hexokinase Reagent – Recall
Audience: Clinical lab managers, hospital risk managers
Pointe Scientific and FDA notified healthcare professionals of a nationwide recall of all size kits of Liquid Glucose Hexokinase Reagent catalog number G7517. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range. Distributors and testing laboratories who have received the Liquid Glucose Hexokinase Reagent (G7517) which is being recalled should destroy remaining inventory. Testing laboratories should consider all test results obtained with the lot numbers listed above to be questionable. The laboratory should inform the patient’s attending physician, and determine, with their input, whether confirmation of the previous test results will be required. Read the complete MedWatch 2009 Safety summary, including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188562.htm | 10/30/2009 7:35 PM | Shujin | | | Cordis CROSSOVER Sheath Introducer – Recall | Cordis CROSSOVER Sheath Introducer – Recall
Audience: Interventional radiological healthcare professionals, hospital risk managers
Cordis and FDA notified healthcare professionals of a nationwide recall of all lots of the CROSSOVER Sheath Introducer, a long-coil reinforced,kink-resistant catheter sheath intended for use in arterial and venous procedures requiring the percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids. The recall was due to stretching or fracture of the sheath during use. In the event of a device fracture, separated segments of the device can embolize downstream in the bloodstream and impede blood flow distal to the point where it lodges, resulting in ischemia or infarct to the distal extremity. Since this device is coil reinforced, any separation of the cannula has the potential to expose portions of the coil creating the potential for vessel dissection or perforation. Unplanned open surgery may be required to remove the retained segments or control bleeding. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188555.htm | 10/30/2009 7:30 PM | Shujin | | | Accusure Insulin Syringes (Qualitest Pharmaceuticals) – Recall | Accusure Insulin Syringes (Qualitest Pharmaceuticals) – Recall
Audience: Diabetes healthcare professionals and patients
Qualitest Pharmaceuticals and FDA notified healthcare professionals of a nationwide recall of Accusure Insulin Syringes. All syringes, regardless of lot number, are subject to this recall. These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots may have needles which detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection. Consumers who have any Accusure insulin syringes should stop using them and contact Qualitest at 1-800-444-4011 for reimbursement. Read the complete MedWatch 2009 Safety summary, including a link to the firm's press release and previous August 2009 recall, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188151.htm | 10/27/2009 10:10 PM | Shujin | | | Rituxan (rituximab) – PML | Rituxan (rituximab) – PML
Audience: Rheumatological healthcare professionals
Genentech and FDA notified healthcare professionals about a third case of progressive multifocal leukoencephalopathy [PML], the first case of PML in a patient with rheumatoid arthritis [RA] treated with Rituxan who has not previously received treatment with a TNF antagonist. Information to date suggests that patients with RA who receive Rituxan have an increased risk of PML. Physicians should consider PML in any patient being treated with Rituxan who presents with new onset neurologic manifestations. Consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated. Read the complete MedWatch 2009 Safety summary, including a link to the Dear Healthcare Professional letter and prescribing information, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187791.htm | 10/27/2009 7:50 PM | Shujin | | | Peramivir IV 2009 H1N1 influenza vaccine | Peramivir IV
Audience: Infectious disease healthcare professionals, hospital risk managers
FDA notified healthcare professionals that, in response to a request from the U.S. Centers for Disease Control and Prevention, it has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital. IV peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an IV drug is clinically appropriate, based on one or more of the following: 1] the patient is not responding to either oral or inhaled antiviral therapy, 2] when drug delivery by a route other than an intravenous route is not expected to be dependable or feasible, or 3] for adults only, when the clinician judges IV therapy is appropriate due to other circumstances. Given there are limited safety data on peramivir, mandatory reporting requirements are important to defining the safety profile of this unapproved drug. As part of the conditions of the EUA, health care providers (or designee) must report adverse events and all medication errors associated with peramivir to FDA’s MedWatch program within 7 calendar days from the onset of the adverse event. Additionally, healthcare providers (or designee) must conduct follow-up requested by FDA or CDC related to peramivir adverse event or medication error reports submitted to FDA. Read the complete MedWatch 2009 Safety summary, including links to the Information for Healthcare Professionals and FDA News Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187814.htm | 10/26/2009 9:35 AM | Shujin | | | Ketorolac Tromethamine Injection |
Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials Recall
Audience: Hospital risk managers, surgical center staff, pharmacists
American Regent and FDA notified healthcare professionals of a voluntary recall of all lots of Ketorolac Tromethamine Injection, USP 30 mg/mL, including NDC# 0517-0801-25 [30 mg/mL 1mL Single Dose Vial] and NDC# 0517-0902-25 [30 mg/mL 2mL Single Dose Vial (60 mg/2mL)]. There is a potential for particulate matter in conjunction with crystallization that may be present in the product, which may result in adverse events such as obstruction of blood vessels which can induce pulmonary emboli or thrombosis, activate platelets and/or neutrophils to induce anaphylactic reactions. Other adverse effects associated with the injection of particulate matter include foreign body granulomas, and local irritation at the injection site. This recall does not include other concentrations of American Regent Ketorolac Tromethamine Injection. The product was distributed to wholesalers and distributors nationwide. Hospitals, surgi-centers, clinics and other healthcare facilities should not use any American Regent Ketorolac Tromethamine Injection, USP Injection 30 mg/mL for patient care and should immediately quarantine any product for return. Read the MedWatch safety summary, including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187481.htm | 10/21/2009 9:30 PM | Shujin | | | Medical Device Power Cords | Medical Device Power Cords Safety Investigation: Initial Communication
Audience: Healthcare professionals, patients/caregivers
[Posted 10/19/2009] FDA is investigating whether certain types of power cords used with medical devices may be defective. Two medical device manufacturers (Hospira, Inc. and Abbott Nutrition) have sent FDA 122 reports of sparking, charring, and fires from the power cords used with their devices. The companies' investigations of these reports determined that the power cord's prongs may crack and fail at/or inside the plug. The potential risks from this power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. Depending on the device and therapy, these failures may potentially lead to serious adverse health consequences, including death. All the reports received so far from Hospira and Abbott have involved AC power cords with a black plastic bridge manufactured by the Electri-cord Manufacturing Company. FDA is aware that Electri-cord has supplied the affected power cords to other medical device manufacturers. The agency is now attempting to determine which devices may be equipped with these cords. FDA recommends that all users of medical devices, either in healthcare facilities or in the home, closely monitor the wear and tear on the electric cords used to power these devices. This vigilance is especially important in oxygen rich environments, in which electrical sparking and arcing may trigger a fire. Read the MedWatch safety summary, including a link to the FDA Initial Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187117.htm | 10/19/2009 4:05 PM | Shujin | | | Dexferrum (iron dextran injection) | Dexferrum (iron dextran injection) - Labeling change
Audience: Hematological healthcare professionals, hospital risk managers
American Regent and FDA notified healthcare professionals that anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. The Boxed Warning has been modified to recommend administering a test dose prior to the first therapeutic dose and observing for signs or symptoms of anaphylactic-type reactions during administration of Dexferrum. Fatal reactions have followed the test dose of iron dextran injection, even in situations where the test dose was tolerated. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions. It is recommended that resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions be readily available during Dexferrum administration. Read the complete MedWatch 2009 Safety summary, including links to the Dear Healthcare professional letter and the revised prescribing information, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186899.htm | 10/16/2009 9:25 PM | Shujin | | | Relenza (zanamivir) Inhalation Powder | Relenza (zanamivir) Inhalation Powder must not be reconstituted in liquid formulation or used in any nebulizer or mechanical ventilator
Audience: Infectious disease healthcare professionals, hospital risk managers
[Posted 10/09/2009] GlaxoSmithKline (GSK) and FDA notified healthcare professionals of a report of the death of a patient with influenza who received Relenza (zanamivir) Inhalation Powder which was solubilized and administered by mechanical ventilation. Relenza (zanamivir) Inhalation Powder is not intended to be reconstituted in any liquid formulation and is not recommended for use in any nebulizer or mechanical ventilator. GSK is aware that Relenza Inhalation Powder is being removed from its FDA-approved packaging and dissolved in various solutions for the purpose of nebulizing zanamivir for inhalation by patients with influenza who are unable to take oral medications or unable to inhale Relenza Inhalation Powder using the Diskhaler. Relenza or zanamivir for nebulization have not been approved by the FDA. The safety, effectiveness, and stability of zanamivir use by nebulization have not been established. Relenza Inhalation Powder should only be used as directed in the prescribing information by using the Diskhaler device provided with the drug product. Relenza Inhalation Powder is a mixture of zanamivir active drug substance and lactose drug carrier. This formulation is not designed or intended to be administered by nebulization. There is a risk that the lactose sugar in this formulation can obstruct proper functioning of mechanical ventilator equipment. Read the MedWatch safety summary, including a link to the Dear Healthcare Professional Letter, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186081.htm | 10/10/2009 10:00 AM | Shujin | | | Unomedical Manual Pulmonary Resuscitator – Recall | Unomedical Manual Pulmonary Resuscitator – Recall
Audience: Pulmonary healthcare professionals, emergency response personnel
Unomedical and FDA notified healthcare professionals about the recall of the single-patient use Manual Pulmonary Resuscitator because of a malfunction which may impair the ability of the device to generate the positive pressure necessary to function properly and could potentially cause serious adverse health consequences or death. The recalled resuscitators were manufactured from July 2002 – March 2008 and the company set up a web page, http://www.unomedical.com/?pageid=H3160 with a list of affected lot numbers, guidance (diagram and photos) to allow customers to identify products subject to the recall in the event that the customer has already removed the primary product packaging, and instructions on what actions to take. Read the complete MedWatch 2009 Safety summary, including links to the firm's press release and product photos, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm185702.htm | 10/10/2009 9:55 AM | Shujin | | | CT Brain Perfusion Scans |
CT Brain Perfusion Scans Safety Investigation: Initial Notification
Audience: Radiological, Neurological and emergency medicine healthcare professionals
[Posted 10/09/2009] FDA notified healthcare professionals that it has become aware of radiation overexposures during perfusion CT imaging performed to aid in the diagnosis of stroke at a particular facility, the patients receiving radiation doses that were approximately eight times the expected level. While this event involved a single kind of diagnostic test at one facility, the magnitude of these overdoses and their impact on the affected patients were significant. This situation may reflect more widespread problems with CT quality assurance programs and may not be isolated to this particular facility or this imaging procedure (CT brain perfusion). If patient doses are higher than the expected level, but not high enough to produce obvious signs of radiation injury, the problem may go undetected and unreported, putting patients at increased risk for long-term radiation effects. FDA encourages every facility performing CT imaging to review its CT protocols and be aware of the dose indices normally displayed on the control panel. These indices include the volume computed tomography dose index and the dose-length product. For each protocol selected, and before scanning the patient, carefully monitor the dose indices displayed on the control panel. To prevent accidental overexposure, make sure that the values displayed reasonably correspond to the doses normally associated with the protocol. Confirm this again after the patient has been scanned. Patients should follow their doctor’s recommendations for receiving CT scans. While unnecessary radiation exposure should be avoided, a medically-needed CT scan has benefits that outweigh the radiation risks. Read the MedWatch safety summary, including a link to the FDA Initial Notification, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186105.htm | 10/10/2009 9:55 AM | Shujin | | | Philips Heartstart Fr2+ Automated External Defibrillators – Recall | Philips Heartstart Fr2+ Automated External Defibrillators – Recall
Audience: Fire departments, emergency medical services personnel, hospitals
Philips and FDA notified healthcare professionals of the recall of 5,400 HeartStart FR2+ automated external defibrillators (AED) due to reports of a memory chip failure which could render the AED inoperable and prevent it from delivering therapy when indicated. The AEDs are used by trained responders and designated response teams to help treat sudden cardiac arrest. The recalled units (models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, distributed by Laerdal Medical) were manufactured between May, 2007 and January, 2008. Philips is contacting customers to arrange for the return and replacement of all the recalled AEDs and set up a page on the Philips Web site -- www.philips.com/FR2PlusAction -- with a serial number look-up tool to allow customers to find out if their FR2+ is part of this recall, as well as instructions on what to do if it is. Read the complete MedWatch 2009 Safety summary, including a link to the firm's press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm185179.htm | 10/10/2009 9:25 AM | Shujin | | | Neuron 6F 070 Delivery Catheter [Penumbra] | Neuron 6F 070 Delivery Catheter [Penumbra]
Audience: interventional neuroradiology healthcare professionals, hospital risk managers
Penumbra and FDA notified healthcare professionals about a voluntary field removal of the original version of Neuron 6F 070 Delivery Catheter due to reports that the catheter could kink or ovalize in certain anatomical situations, lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter. Continued usage of a kinked catheter could cause the catheter to break, which could result in a portion being retained in the patient, which could result in additional procedural time, patient injury or death. There are four injury reports to date, which may be potentially associated with this defect. Facilities that have the older version of 6F Neuron 070 Delivery Catheter which is being recalled should stop using and return the device. Penumbra is notifying affected hospitals through detailed Field Removal notification letters requesting that affected product be returned to Penumbra. The affected product catalog numbers and lot numbers are provided in the firm press release. Read the complete MedWatch 2009 Safety summary, including a link to the firm Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm184742.htm | 10/1/2009 7:25 PM | Shujin | | | Neocate Infant Specialized Formula – Recall | Neocate Infant Specialized Formula – Recall
Audience: Pediatric healthcare professionals, pharmacists, caregivers
Nutricia and FDA notified healthcare professionals of the voluntary recall of one lot [# P91877] of the specialized infant formula product, Neocate, a hypoallergenic dry powder formula distributed to pharmacies, health care professionals and consumers nationwide. Due to a blending error, Neocate contained protein levels lower than that declared on the label. Although short-term consumption of product from the affected batch is very unlikely to cause immediate nutritional issues, longer term consumption might influence the healthy growth curve in certain infants. Neocate is not intended for general use and is usually given to infants in the care of health care professionals. The affected cans were distributed between September 1 and September 11, 2009 and the lot number can be found at the bottom of each can and on the right hand side of the case label. Read the complete MedWatch 2009 Safety summary, including a link to the firm press release and product photo, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm184129.htm | 9/29/2009 1:55 PM | Shujin | | | Children's and Infants' Tylenol Oral Suspension Products – Recall | Children's and Infants' Tylenol Oral Suspension Products – Recall
Audience: Consumers and Healthcare professionals
McNeil Consumer Healthcare and FDA notified consumers of a nationwide recall of certain Tylenol products as a precautionary measure because of potential manufacturing problems. The company initiated a recall of certain oral suspension products distributed between March 2008 and May 2008 due to the potential of bacteria in raw materials used to manufacture the finished product. There are no illnesses reported by patients using this product. The full list of recalled product lots can be accessed on the company’s website at http://www.tylenolprofessional.com/assets/TYLENOL_Letter_091809.pdf. McNeil is advising parents and caregivers who have administered affected product to their child or infant and have concerns to contact their healthcare providers. Parents and caregivers can find the lot numbers on the bottom of the box containing the product and also on the sticker that surrounds the product bottle. Read the complete MedWatch 2009 Safety summary including a link to the FDA news release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm183924.htm | 9/25/2009 10:30 PM | Shujin | | | Exjade (deferasirox) | Exjade (deferasirox) - Early Communication
Audience: Hematology-Oncology healthcare professionals
FDA notified healthcare professionals of an Early Communication regarding an ongoing review of safety issues with Exjade (deferasirox). New safety data suggests there may be a greater number of adverse events and deaths in patients using Exjade who are over sixty years old who have myelodysplastic syndrome (MDS). Exjade, an iron chelator, is an oral medication approved in 2005 for patients aged two and older with chronic anemia (low red blood cell counts) and iron overload as a result of receiving blood transfusions. FDA is working with Novartis to add new information in the Contraindications, Warnings, and Precautions sections of the prescribing information, to alert healthcare professionals of the risks and adverse events, including acute renal failure and gastrointestinal hemorrhages that in rare cases, especially in older patients with blood-related malignancies and/or low platelet counts, have been fatal. Read the complete MedWatch 2009 Safety summary, including a link to the Early Communication document, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm183840.htm | 9/25/2009 4:35 PM | Shujin | | | Sitagliptin (Januvia and Janumet) | Sitagliptin (marketed as Januvia and Janumet) - acute pancreatitis
Audience: Diabetes healthcare professionals, patients
FDA notified healthcare professionals and patients of revisions to the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products. Eighty-eight post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to the Agency between October 2006 and February 2009. It is recommended that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin. Sitagliptin has not been studied in patients with a history of pancreatitis. Therefore, it is not known whether these patients are at an increased risk for developing pancreatitis and the medication should be used with caution and with appropriate monitoring in patients with a history of pancreatitis. Considerations for healthcare professionals, information for patients, and a Data Summary are provided. Read the complete MedWatch 2009 Safety summary including a link to the Information for Healthcare Professionals sheet, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm183800.htm | 9/25/2009 12:30 PM | Shujin | | | Medtronic Neuromodulation | Medtronic Neuromodulation, INDURA 1P Intrathecal Catheter, Intrathecal Catheter, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit
Audience: Physical medicine and rehabilitation specialists, anesthesia healthcare professionals, hospital surgical service managers
FDA notified healthcare professionals of the Class 1 recall of Medtronic SC Catheters and Revision Kit Models: 8709SC, 8731SC, 8578, and 8596SC when paired with the Medtronic IsoMed Pump Model 8472, due to a design incompatibility resulting in a physical interference between the SC catheter connector and the IsoMed pump. This may prevent the SC catheter from completely connecting to the IsoMed pump, even though it may appear to be connected and feel secure and may lead to disruptions of therapy and revision surgery, which pose a risk of serious injury or death. SC catheters are not compatible with IsoMed pumps but are compatible with Medtronic SynchroMed II and SynchroMed EL pumps. To date, Medtronic has received ten reports worldwide related to improper connection of an SC catheter to an IsoMed pump. In all ten reports, medical intervention was required to correct the condition. Medtronic has provided recommendations in their Medical Device Correction Letter (see link in FDA Recall Notice). Read the complete MedWatch 2009 Safety summary, including a link to the Class 1 recall notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm183753.htm | 9/25/2009 1:00 AM | Shujin | | | Tamiflu (oseltamivir) |
Tamiflu (oseltamivir) for Oral Suspension: Potential Medication Errors
Audience: Pharmacists, pediatrics healthcare professionals
FDA issued a Public Health Alert to notify prescribers and pharmacists about potential dosing errors with Tamiflu (oseltamivir) for Oral Suspension. U.S. health care providers usually write prescriptions for liquid medicines in milliliters (mL) or teaspoons, while Tamiflu is dosed in milligrams (mg). The dosing dispenser packaged with Tamiflu has markings only in 30, 45 and 60 mg. The Agency has received reports of errors where dosing instructions for the patient do not match the dosing dispenser. Health care providers should write doses in mg if the dosing dispenser with the drug is in mg. Pharmacists should ensure that the units of measure on the prescription instructions match the dosing device provided with the drug. Read the complete MedWatch 2009 Safety summary, including links to the FDA Public Health alert, Dear Healthcare Professional letter [Roche] and Information for Pharmacists [CDC], at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm183714.htm | 9/25/2009 12:55 AM | Shujin | | | Natalizumab (marketed as Tysabri) | Natalizumab (marketed as Tysabri)
Audience: Neurological healthcare professionals, patients
[Posted 09/17/2009] FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri. Tysabri was approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS) in November 2004 and for moderately to severely active Crohn’s disease in January 2008. From July 2006, (when Tysabri marketing resumed) to September 8, 2009, 13 reported cases of Tysabri-related PML were confirmed worldwide in patients being treated for MS with Tysabri monotherapy. There have been no postmarketing reports of PML in patients treated with Tysabri for Crohn’s disease. Less than 2% of Tysabri use in the U.S. has been in patients with Crohn's disease. Based on available data from the U.S. and outside of the U.S., the current rate of PML in patients who have received at least 24 infusions ranges from 0.4 to 1.3 per 1,000 patients. The risk for developing PML appears to increase with the number of Tysabri infusions received. At this time, the FDA is not requiring changes regarding PML to the Tysabri prescribing information or to the Tysabri risk management plan, called the TOUCH Prescribing Program. Read the MedWatch safety summary, including a link to the "Information for Healthcare Professionals" page, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm182667.htm | 9/22/2009 2:30 PM | Shujin | | | Promethazine Hydrochloride Injection |
Promethazine Hydrochloride Injection
Audience: All healthcare professionals
FDA notified healthcare professionals that a Boxed Warning is being added to the prescribing information for Promethazine Hydrochloride products, describing the risks of severe tissue injury, including gangrene, requiring amputation following intravenous administration of promethazine. The Boxed Warning will remind practitioners that due to the risks of intravenous injection, the preferred route of administration is deep intramuscular injection and that subcutaneous injection is contraindicated. Perivascular extravasation, unintentional intra-arterial injection and intraneuronal or perineuronal infiltration of the drug may result in irritation and tissue damage. Healthcare professionals should be alert for signs and symptoms of potential tissue injury including burning or pain at the site of injection, phlebitis, swelling, and blistering. Read the complete MedWatch 2009 Safety summary including links to the Information for Healthcare Professionals sheet and News Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm182500.htm | 9/16/2009 2:55 PM | Shujin | | | LIFEPAK CR Plus Automated External Defibrillators | LIFEPAK CR Plus Automated External Defibrillators (Physio-Control, Inc)
Audience: Emergency medical personnel, consumers
FDA notified healthcare professionals of a Class I recall of certain LIFEPAK CR Plus Automated External Defibrillators (AED) manufactured and distributed from July 9, 2008 through August 19, 2008. An extremely humid environment may cause the affected devices to improperly analyze the heart rhythm and may cause the device to delay or fail to deliver therapy. Any adverse events or quality problems that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail or fax [1-800-FDA-0178]. Read the complete MedWatch 2009 Safety summary, including a link to the Class 1 recall notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm182496.htm | 9/16/2009 2:50 PM | Shujin | | | Portex Uncuffed Pediatric-Sized Tracheal Tubes | Portex Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm)
Audience: Anesthesiology healthcare professionals, hospital risk managers
Smiths Medical and FDA notified healthcare professionals about a nationwide voluntary recall of Portex Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm). A small number of tubes were manufactured with internal diameters slightly smaller than indicated on the labeling, which may create the potential for the clinician to experience difficulty passing through or withdrawing the suction catheter. The health consequences that may result from use of the defective device include the inability to remove secretions from the device and from the patient's airway, which may result in partial or complete obstruction of the airway and an inability to ventilate the patient. In addition, this defect may increase airway resistance and compromise the ability to ventilate the patient. There is a reasonable probability of serious injury and/or death. Smiths Medical is instructing customers to return all unused Tracheal Tubes and in their press release has provided recommendations for management of recalled product that is currently in use. Read the complete MedWatch Safety summary, including a link to the firm's press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm182084.htm | 9/15/2009 10:50 PM | Shujin | | | Covidien Pedi-Cap End-Tidal CO2 Detector |
Covidien Pedi-Cap End-Tidal CO2 Detector
Audience: Anesthesiology healthcare professionals, hospital risk managers, surgical service managers
FDA notified healthcare professionals of a Class I recall of Pedi-Cap End-Tidal CO2 Detector (Pedi-Cap and Pedi-Cap 6), because the device may increase the resistance of the flow of air into the lungs, resulting in ineffective ventilation and the inability to verify the correct placement of a breathing tube when inserting it into the windpipe. This device is used in pediatric patients, weighing 2.2-33 pounds, during the process of exchanging oxygen for carbon dioxide (ventilation) in healthcare settings. There is a reasonable probability that use of the recalled PediCap will cause serious adverse health consequences or death. Covidien informed their distributors and customers to stop selling/using the affected devices and to return them to the company. Any adverse events or quality problems that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail or fax [1-800-FDA-0178]. Read the complete MedWatch 2009 Safety summary, including a link to the recll notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181878.htm | 9/10/2009 4:35 PM | Shujin | | | ConMed Linvatec - Universal Cables and Power Pro |
ConMed Linvatec - Universal Cables and Power Pro Handpieces
Audience: Orthopedic surgical healthcare professionals, hospital risk managers, surgical service managers
FDA notified healthcare professionals of the Class 1 recall of two ConMed Linvatec surgical service products due to reports of a switch problem resulting in unintended self-activation of these powered tools, continued running after trigger release and tool movement in unintended directions. The products are:
• Power Pro, Power ProMax, and MPower 1 Handpieces, powered surgical handpieces in which a number of surgical tools (such as drills, blades, and small cutting devices) can be attached and are used during orthopedic surgical procedures.
• Universal Cables, MC5057, the cable connects Linvatec MicroChoice Small Bone, MicroChoice, Advantage and APEX Shaver System and Power Pro Electric I and II Large Bone System electric handpieces to the power source. The handpieces were distributed from March 29, 2002 through June 24, 2009. The cables were distributed from January 24, 2001 through February 27, 2009. ConMed has instructed users to stop using the cable immediately if the handpiece self-activates or an intermittent operation occurs and to return the handpiece and cable to the company for evaluation. Any adverse events or quality problems that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail or fax [1-800-FDA-0178]. Read the complete MedWatch 2009 Safety summary, including links to the two recall notices and the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181833.htm | 9/10/2009 4:15 PM | Shujin | | | Penumbra Neuron 5F Select Catheter | Penumbra Neuron 5F Select Catheter
Audience: Neurosurgical and invasive radiology healthcare professionals, hospital risk managers
Penumbra and FDA notified healthcare professionals of the Class 1 recall of the Neuron 5F Select Catheter, used to remove blood clots or foreign objects from blood vessels. Due to a manufacturing error, the catheters may contain pin holes and exposed wire braids which may result in a brain clot or a blood vessel puncture, and this may lead to possible death. The device was distributed from May 5, 2009 through June 12, 2009. Any adverse events or quality problems that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178]. Read the complete MedWatch Safety summary, including a link to the FDA recall notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181725.htm | 9/10/2009 4:00 PM | Shujin | | | Philips Avalon Fetal Monitors | Philips Avalon Fetal Monitors
Audience: Obstetric healthcare professionals, hospital risk managers
FDA issued a Dear Healthcare Provider Letter to notify healthcare professionals and facilities of a number of complaints of inaccurate readings when using the Philips Avalon Fetal Monitors, Models FM20, FM30, FM40, and FM50 with the ultrasound transducer. On September 4, 2009, Philips issued an Important Device Safety Alert. Inaccurate output readings, if not properly addressed, may lead to unnecessary interventions, failure to identify the need for interventions, and failure to identify fetal distress. The complaints most commonly occur during the second stage of labor. Recognizing these conditions and responding appropriately is important to avoiding serious adverse health consequences. The Philips alert describes the most common complaints reported, steps for the user to minimize the risk, and urges the user to review the Instructions for Use for Philips Avalon Fetal Monitors. Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178]. Read the complete MedWatch 2009 Safety summary including a link to the FDA Dear Provider letter and the Phillips Healthcare alert, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181505.htm | 9/5/2009 11:55 PM | Shujin | | | Myfortic (mycophenolic acid) (Correction) |
Myfortic (mycophenolic acid)
Audience: Renal, cardiac, and hepatic transplantation healthcare professionals
Novartis and FDA notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with Myfortic. The WARNINGS and ADVERSE REACTIONS sections of the Myfortic Prescribing Information have been revised to reflect this new safety information. PRCA is a type of anemia in which there is a selective reduction of red blood cell precursors on bone marrow examination. Patients with PRCA may present with fatigue, lethargy, and/or abnormal paleness of the skin (pallor). In some cases, PRCA was found to be reversible with dose reduction or cessation of Myfortic therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk. Read the complete MedWatch Safety summmary (corrected) at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181306.htm | 9/5/2009 12:00 AM | Shujin | | | Remicade, Enbrel, Humira, Cimzia, and Simponi | Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) Updated
Audience: Rheumatologists, gastroenterologists, oncologists, dermatologists
[UPDATED 08/31/2009] Supplemental Q&As added.
[Original Posting 08/04/2009] FDA notified healthcare professionals that it has completed its analysis of tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. This new safety information is now being added to the Boxed Warning for these products. FDA has also identified new safety information related to the occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers. The current prescribing information for TNF blockers does contain a warning for malignancies, but does not specifically mention leukemia. FDA is also requiring updates to the current Medication Guide to help patients understand the risks associated with TNF blocker therapy. Read the complete MedWatch 2009 Safety summary including the Update of Q&A's that provide supplemental information to the original August 4, 2009 safety alert, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm175843.htm | 8/31/2009 9:25 PM | Shujin | | | Intelence (etravirine) | Intelence (etravirine)
Audience - Infectious Disease healthcare professionals, patients
Tibotec Therapeutics and FDA notified healthcare professionals of revisions to the WARNINGS AND PRECAUTIONS section of the prescribing information for Intelence (etravirine). There have been postmarketing reports of cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme, as well as hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure. Intelence therapy should be immediately discontinued when signs and symptoms of severe skin or hypersensitivity reactions develop. Read the complete MedWatch 2009 Safety Summary, including a link to the Dear healthcare professional letter, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm180579.htm | 8/27/2009 7:20 AM | Shujin | | | Levemir Insulin | Levemir Insulin (Novo Nordisk)
Audience: Patients, pharmacists, diabetes healthcare professionals
[UPDATED 08/26/2009] FDA is reminding the public that stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. still may be on the market. Evidence gathered to date suggests that the stolen insulin was not stored and handled properly and may be dangerous for people to use. FDA has received multiple reports of patients who suffered an adverse event due to poor control of glucose levels after using a vial from one of the stolen lots. Read the complete MedWatch 2009 Safety summmary including a link to the FDA News release and the original June 13,2009 alerts at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166359.htm | 8/26/2009 6:15 PM | Shujin | | | Stabilet Infant Warmer | Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 [Dräeger/Hill-Rom]
Audience: Pediatric and Obstetric Healthcare professionals, hospital risk managers
[UPDATED 08/25/2009; original alert 07/22/2009] FDA notified healthcare professionals of a Class 1 recall of these models of the Stabilet infant warmer because these out-of-date devices may cause serious injury to infants and caregivers due to the possibility that the warmer might be the ignition source for a fire. On July 20, 2009, Draeger sent a recall letter to all known customers, requested customers remove the affected devices from service, remove the heating element and the power cord to make the device unusable once removed from service and emphasized these devices are not to be used, donated or sold for any other purpose. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death. Read the complete MedWatch 2009 Safety summmary including the July 22 alert and a link to the FDA recall notice and firm recall letter, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm173239.htm | 8/25/2009 7:35 PM | Shujin | | | Accusure Insulin Syringes | Accusure Insulin Syringes [31G, 1/2 cc and 1 cc]
Audience: Patients with diabetes mellitus, pharmacists and diabetes healthcare professionals
Qualitest Pharmaceuticals and FDA notified patients and healthcare professionals of a voluntary nationwide recall of two lots of Accusure Insulin Syringes. The syringes in these lots have been found to have needles which can detach from the syringe. When the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after an injection. Consumers who have any recalled Accusure Insulin Syringes (31 G –Short Needle-either 1/2 cc or 1 cc, lot number 6JCB1 or lot number 7CPT1) should stop using them and contact Qualitest at 1-800-444-4011 for product replacement instructions. The lot number can be found on the white paper backing of each individual syringe. These recalled products were distributed from January 2007 through June 2008 to wholesalers and retail pharmacies nationwide (including Puerto Rico). Read the complete MedWatch 2009 Safety summmary including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm179955.htm | 8/24/2009 10:25 PM | Shujin | | | Orlistat (marketed as Alli and Xenical) | Orlistat (marketed as Alli and Xenical): Early Communication about an Ongoing Safety Review
Audience: Endocrinological healthcare professionals, patients
FDA notified healthcare professionals and patients that it is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat. Orlistat is marketed in the United States as a prescription product, Xenical, and as an over-the-counter (OTC) product, Alli. Between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat were submitted to FDA’s Adverse Event Reporting System. The most commonly reported adverse events described in the 32 reports of serious liver injury were jaundice, weakness, and abdominal pain. FDA is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat, analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time. FDA is not advising healthcare professionals to change their prescribing practices with orlistat. Consumers currently taking Xenical should continue to take it as prescribed and those using over-the-counter Alli should continue to use the product as directed.
FDA urges both healthcare professionals and consumers to report side effects from the use of orlistat (Alli and Xenical) to FDA's MedWatch Adverse Event Reporting program. Read the complete MedWatch Safety summary, including links to the Early Communication and FDA News Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm180025.htm | 8/24/2009 10:20 PM | Shujin | | | Ibuprofen (Unapproved) topical drug products | Ibuprofen (Unapproved) topical drug products
Audience: Consumers, pharmacists
FDA informed consumers and healthcare professionals of its intent to take action against eight companies that market unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen. The products, which contain ibuprofen in combination with a variety of other active ingredients and are marketed for pain relief, are unapproved new drugs that require an approved new drug application in order to be legally marketed. Orally administered ibuprofen has been approved as a safe and effective treatment for pain and inflammation. There are no approved applications for topical ibuprofen products. Topical ibuprofen is often promoted as a “safer” alternative that can be used in place of oral ibuprofen because of certain side effects, such as stomach ulcers and cardiovascular effects that are associated with prolonged use of oral ibuprofen. However, these safety claims for topical ibuprofen have not been reviewed by the FDA, nor has the agency evaluated what side effects might be associated with such products.
The names of the products and manufacturers that received warning letters are:
Emuprofen (Progressive Emu, Inc.)
BioEntopic 15% Ibuprofen Crème (BioCentric Laboratories, Inc..)
Ibunex Topical Ibuprofen (Core Products International, Inc.)
LoPain AF 15% Ibuprofen Crème (Geromatrix Health Products)
IB-RELIEF (MEKT LLC)
Profen HP (Ridge Medical Products)
IbuPRO-10 Plus (Meditrend, Inc. dba Progena Professional Formulations)
IBU-RELIEF 12 (Wonder Laboratories)
Read the complete MedWatch 2009 Safety summary including a link to the FDA press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm179925.htm | 8/21/2009 6:55 PM | Shujin | | | Hospira, Inc. Device Recall | Hospira, Inc. Device Recall
Audience: Hospital Risk Managers
[Posted 08/17/2009] Hospira and FDA notified healthcare professionals and patients of a nationwide recall of devices that have defective AC power cords in response to customer reports of sparking, charring and fires on the plug of the power cord. Hospira's investigation of these reports determined that the power cord's prongs may crack and fail at or inside the plug. The potential risks from this power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires which may also occur in an oxygen-rich environment. Depending on the device and therapy, these failures may lead to potential serious injury or death. Users with affected power cords that have bent or cracked prongs, burnt plastic or excessive wear and tear should discontinue use immediately and contact their Hospira sales representative or Hospira Technical Support Operations at 1-800-241-4002 (available from 6 a.m. to 4 p.m., Pacific time) for instructions on receiving replacement parts or devices.
For a list of the recalled devices http://www.fda.gov/Safety/Recalls/ucm178158.htm. Read the complete MedWatch 2009 Safety summary, including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm179004.htm | 8/17/2009 2:35 PM | Shujin | | | Mixed Salts of a Single Entity Amphetamine Product | Barr Laboratories, Inc. issued a voluntary recall of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single Entity Amphetamine Product) 20mg Tablets, 100 count bottles, lot number 311756. The product is being recalled because the affected lot may contain some tablets exceeding weight requirements which may lead to super-potent tablets. Clinically significant adverse reactions to a supratherapeutic dose could include cardiovascular, neurologic, psychiatric and gastrointestinal reactions. Customers who have this lot in their possession are instructed to cease using the product and return it to their pharmacy/distributor. Read the MedWatch safety summary, including a link to the firm's Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm177434.htm | 8/14/2009 4:20 PM | Shujin | | | Pure Red Cell Aplasia (PRCA) | FDA and Roche notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with CellCept. The WARNINGS and ADVERSE REACTIONS sections of the CellCept Prescribing Information have been revised to reflect this new safety information. PRCA is a type of anemia in which there is a selective reduction of red blood cell precursors on bone marrow examination. Patients with PRCA may present with fatigue, lethargy, and/or abnormal paleness of the skin (pallor). In some cases, PRCA was found to be reversible with dose reduction or cessation of CellCept therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk. Read the MedWatch safety summary, including links to the Dear Healthcare Professional Letter and revised Prescribing Information, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm177397.htm | 8/14/2009 12:15 PM | Shujin | | | GDH-PQQ Glucose Monitoring Technology | GDH-PQQ Glucose Monitoring Technology: possibility of falsely elevated blood glucose results
Audience: Diabetes healthcare professionals, hospital risk managers, patients
[Posted 08/13/2009] FDA notified healthcare professionals of the possibility of falsely elevated blood glucose results when using GDH-PQQ glucose test strips on patients who are receiving therapeutic products containing certain non-glucose sugars. These sugars can falsely elevate glucose results, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death. GDH-PQQ glucose monitoring measures a patient’s blood glucose value using methodology that cannot distinguish between glucose and other sugars. Certain non-glucose sugars, including maltose, xylose, and galactose, are found in certain drug and biologic formulations, or can result from the metabolism of a drug or therapeutic product. The FDA Public Health Notification provides a list of GDH-PQQ Glucose Test Strips and recommends that healthcare practitioners avoid using GDH-PQQ glucose test strips in healthcare facilities or take steps to never use them on patients receiving interfering substances. FDA encourages the voluntary reporting of any medical device adverse events related to glucose meters or glucose test strips that do not meet the requirements for mandatory reporting. Adverse events should be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178]. Read the complete MedWatch 2009 Safety summary, including links to the Public Health Notification and Advice for Patients, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm177295.htm | 8/13/2009 6:20 PM | Shujin | | | Botox and Botox Cosmetic | Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B)
Audience: Cosmetic surgeons, neurologists, consumers
[UPDATED 08/03/2009 from original 04/06/2009 alert] FDA notified healthcare professionals of changes to the established drug names for Botox/Botox Cosmetic, Dysport and Myobloc to reinforce individual potencies and prevent medication errors, and provided recommendations for healthcare professionals to consider, plus information for patients, family members, and caregivers. Read the complete MedWatch 2009 Safety summary including a link to the original alert and the update Information for Healthcare Professionals document, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm164255.htm | 8/7/2009 8:55 AM | Shujin | | | Remicade, Enbrel, Humira, Cimzia, and Simponi | Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi)
Audience: Rheumatologists, gastroenterologists, oncologists, dermatologists
FDA notified healthcare professionals that it has completed its analysis of tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. This new safety information is now being added to the Boxed Warning for these products. FDA has also identified new safety information related to the occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers. The current prescribing information for TNF blockers does contain a warning for malignancies, but does not specifically mention leukemia. FDA is also requiring updates to the current Medication Guide to help patients understand the risks associated with TNF blocker therapy. TNF blockers are approved for the treatment of one or more of a number of immune system diseases including juvenile idiopathic arthritis (JIA), rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease, and ankylosing spondylitis. Read the complete MedWatch 2009 Safety summary, including links to the Information for Healthcare Professionals sheet with recommendations for providers and for patients, and data summaries for the lymphoma, leukemia and psoriasis analyses, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm175843.htm | 8/7/2009 8:50 AM | Shujin | | | Alaris System (recall) | Alaris System (Cardinal Health)
Audience: Hospital risk managers
FDA notified healthcare professionals of the Class 1 recall of various modules of Cardinal Health’s Alaris System, electronic infusion pumps that deliver controlled amounts of medications or other fluids to patients through an intravenous, intra-arterial, epidural, and other routes of administration. The firm initiated the recall after identifying five problems that affected the Alaris System, including failure of the occlusion warning message, syringe volume warning message, electrostatic discharge protection circuitry and fluid ingress tubing. It was determined that the five failures may result in patients experiencing under- or over-infusion which may result in serious injury or death.The device is intended for use with adult and pediatric patients in hospitals including critical care units, emergency rooms, outpatient surgical centers, hospices, and nursing homes. Read the complete MedWatch 2009 Safety summary, including a link to the FDA Recall notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm174797.htm | 8/7/2009 8:45 AM | Shujin | | | Steam Dietary Supplement | Steam Dietary Supplement
Audience: Consumers, pharmacists
Nutracoastal Trading LLC and FDA notified healthcare professionals and consumers of a nationwide recall of the company's dietary supplement product sold under the name Steam. Lab analysis by FDA found that the product contains sulfoaildenafil, an analog of sildenafil. Sildenafil is an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making Steam an unapproved drug. The undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Additionally, the product may cause side effects, such as headaches and flushing. The recalled product was distributed in white plastic bottles to retail stores nationwide. Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178]. Read the complete MedWatch Safety summary including a link to the firm press release and photo of product, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm174339.htm | 7/30/2009 11:45 PM | Shujin | | | POWERSAIL Coronary Dilatation Catheters | POWERSAIL Coronary Dilatation Catheters
Audience: Cardiovascular surgery healthcare professionals, hospital risk managers, surgical service supervisory staff
Abbott and FDA notified healthcare professionals of the national Class 1 recall of three lots of POWERSAIL Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of four complaints that the distal shaft of the catheter exhibited damage. The damage may cause a leak of contrast material during use, which could lead to catheter functional failures and clinical consequences, including air embolism and myocardial infarction, which has the potential to lead to death. Customers with questions or concerns should contact their Abbott Vascular Representative or call the company at 1-800-227-9902. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178]. Read the complete MedWatch 2009 Safety summary, including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm174608.htm | 7/30/2009 8:15 PM | Shujin | | | Colchicine (marketed as Colcrys) | Colchicine (marketed as Colcrys)
Audience: Rheumatological healthcare professionals
FDA notified healthcare professionals of the approval of the first single-ingredient oral colchicine product, Colcrys, for the treatment of familial Mediterranean fever (FMF) and acute gout flares and of two previously uncharacterized safety concerns associated with the use of colchicine. Oral colchicine has been used for many years as an unapproved drug with no FDA-approved prescribing information, dosage recommendations, or drug interaction warnings. FDA analyzed safety data for colchicine from adverse events reported to the Agency, the published literature, and company-sponsored pharmacokinetic and drug interaction studies. This analysis revealed cases of fatal colchicine toxicity reported in certain patients taking standard therapeutic doses of colchicine and concomitant medications that interact with colchicine, such as clarithromycin. These reports suggest that drug interactions affecting the gastrointestinal absorption and/or hepatic metabolism of colchicine play a central role in the development of colchicine toxicity. Data submitted supporting the safety and efficacy of Colcrys in acute gout flares demonstrated that a substantially lower dose of colchicine was as effective as the higher dose traditionally used. Moreover, patients receiving the lower dose experienced significantly fewer adverse events compared to the higher dose. Based on this information, FDA has included important safety considerations in the approved prescribing information to assure safe use of Colcrys and is providing background information, a data summary and recommendations in this alert. Read the complete MedWatch Safety summary, including a link the the Information for Healthcare Professionals page with a data summary and patient management recommendations, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm174596.htm | 7/30/2009 8:10 PM | Shujin | | | Body Building Products | Body Building Products (Marketed as Containing Steroids or Steroid-like Substances)
Audience: Consumers and all healthcare professionals
FDA notified both healthcare professionals and their patients about new safety information concerning products marketed for body building and increasing muscle mass, frequently marketed as alternatives to anabolic steroids for increasing muscle mass and strength and sold both online and in retail stores. These products are promoted to athletes to improve sports performance and to aid in recovery from training and sporting events. Although marketed as dietary supplements, they are not dietary supplements, but instead are unapproved new drugs that have not been reviewed by the FDA for safety and effectiveness. Adverse event reports received by the FDA for body building products that are labeled to contain steroids or steroid alternatives involve men and include cases of serious liver injury, stroke, kidney failure and pulmonary embolism (blockage of an artery in the lung). Due to the potentially serious health risks associated with using these types of products, the FDA recommends that consumers immediately stop using all body building products that claim to contain steroids or steroid-like substances. Health care professionals are advised to ask their patients about any over-the-counter products they may be using, including products marketed as dietary supplements. Health care professionals and consumers are encouraged to report any adverse events related to the use of these products to FDA's MedWatch Adverse Event Reporting program, either online, by regular mail or by fax [link in footer below]. Read the complete MedWatch 2009 Safety summary, including links to the FDA public health advisory, news release and consumer update, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm173983.htm | 7/28/2009 5:35 PM | Shujin | | | Electronic Cigarettes | Electronic Cigarettes
Audience: Pediatric healthcare professionals and consumers
FDA notified healthcare professionals and patients that a laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze. Electronic cigarettes, also called “e-cigarettes,” are battery-operated devices that generally contain cartridges filled with nicotine, flavor and other chemicals. The electronic cigarette turns nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user. These products are marketed and sold to young people and are readily available online and in shopping malls. They are also available in different flavors, such as chocolate and mint, which may appeal to young people. The FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDA’s analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. These products do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes. Because these products have not been submitted to the FDA for evaluation or approval, at this time the agency has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the amounts or kinds of other chemicals that the various brands of these products deliver to the user. Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of e-cigarettes to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone. Read the complete MedWatch 2009 Safety summary, including links to FDA supporting information, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm173327.htm | 7/22/2009 10:20 PM | Shujin | | | Stabilet Infant Warmer |
Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 [Draeger/Hill-Rom]
Audience: Pediatric and Obstetric Healthcare professionals, hospital risk managers
Draeger Medical and FDA notified healthcare professionals that it recommends the removal of Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 from service as soon as possible due to concern that continued use of these devices may result in serious injury to the patient and/or caregiver. A January 2008 fire in a Minnesota neonatal unit injured an infant and an independent investigation concluded that the Hill-Rom Stabilet 1250 was likely the ignition source of the fire. Draeger agrees with the recommendation to remove the referenced Stabilet models from service immediately. Immediate actions required include:
· Locate and identify the devices listed in this notice.
· Remove the referenced devices from service as soon as possible.
· If an infant is currently receiving therapy from one of the referenced devices, consider the risk of moving the patient before changing to an alternative mode of therapy.
· Once removed from service, the warmers should be rendered unusable by removing the heating element and the power cord. These warmers should not be used or sold for any other purpose. A recall notification is being sent out to all known current users and is available in the Draeger website at www.draeger.com/Stabilet. Health care professionals and consumers should report serious adverse events (side effects) or product quality problems with the use of this product to Draeger Medical Systems Inc. or to the FDA MedWatch Adverse Event reporting Program, www.fda.gov/medwatch/report.htm. Read the complete MedWatch 2009 Safety summary, including a link to the updated firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm173239.htm | 7/22/2009 10:15 PM | Shujin | | | Nuby Gel Filled Cottontails and Teethers: recall | Nuby Gel Filled Teethers and certain Cottontails and Playschool Teethers: Nationwide recall
Audience: Consumers,Parents and Pediatric healthcare professionals
Luv N’ Care and FDA notified all consumers/parents and healthcare professionals of a nationwide recall of Nuby Gel Filled, Cottontails, and Playschool Teethers. The firm recalled the products after learning that samples of two lots collected by FDA were found to contain Bacillus subtilis and Bacillus circulans in the gel. These bacteria generally do not cause illness, but bacteria can affect children with weakened immune systems, causing stomach pain, vomiting, and diarrhea, if the teether is punctured and the liquid from the teether is ingested. Product was distributed through retail outlets nationwide and has been found to be marketed on the internet. The products are packaged in a plastic bubble on a printed card and can be identified by the UPC Codes listed. Consumers who have Nuby Gel Filled Teethers and Cottontails and Playschool Teethers with any of the UPC Codes listed should immediately stop using them, discard them or return them to the place of purchase. Read the complete MedWatch 2009 Safety summary, including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm172712.htm | 7/18/2009 9:45 PM | Shujin | | | Propofol Injectable Emulsion (recall) | Teva Pharmaceuticals and FDA notified healthcare professionals of a recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B. The product lots identified are being recalled due to the presence of elevated endotoxin levels in some vials within these lot numbers. Teva has been notified of 41 propofol-treated patients who experienced post-operative fever, chills and other flu-like symptoms. Adverse health effects, such as fever, chills, or rigors, are possible with exposure to product with elevated levels of endotoxins. Serious adverse effects, such as disseminated intravascular coagulopathy, acute respiratory distress syndrome, shock, and death, are possible with exposure to product with high endotoxin levels. Customers who have Propofol lots 31305429B and 31305430B in their possession are instructed to cease using the product and return it to their distributor. Read the MedWatch safety summary, including a link to the firm's Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm172507.htm | 7/17/2009 7:30 PM | Shujin | | | Weight loss dietary supplements | Young You Corporation and FDA notified healthcare professionals and consumers that four weight loss dietary supplements sold and marketed by the firm (Slimbionic, One Weight Loss Pill, SlimDemand Capsules, Botanical Weight Loss) contain an undeclared drug ingredient, Sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved the products as drugs; therefore the safety and effectiveness of this product is unknown. FDA advises that these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. The products were sold and distributed nationwide via the internet and at the company’s Weight Loss and Rejuvenation Center in Tarzana, Ca. Read the MedWatch safety summary, including a link to the firm's Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm172527.htm | 7/17/2009 7:30 PM | Shujin | | | Xolair (omalizumab) |
FDA is evaluating interim safety findings from an ongoing study of Xolair (omalizumab) titled Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS) that suggests a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events in patients treated with Xolair compared to the control group of patients not given the drug. Xolair is approved for use by adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who test positive for reactivity to a perennial airborne allergen, and whose symptoms are inadequately controlled with inhaled corticosteroids. FDA is not recommending any changes to the prescribing information for Xolair and is not advising patients to stop taking Xolair at this time. Until the evaluation of the EXCELS study is completed, healthcare providers and patients should be aware of the risks and benefits described in the prescribing information, as well as the new information from the ongoing EXCELS study that may suggest a risk of cardiovascular and cerebrovascular adverse events. Read the MedWatch safety summary, including a link to the Early Communication about an Ongoing Safety Review, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm172406.htm | 7/16/2009 6:45 PM | Shujin | | | Nature & Health Co. male enhancement products | Nature & Health Co., announced a voluntary nationwide recall of the company's supplement products sold under the following names: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac. Lab analysis by FDA of these products found they contain either tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED), its analog aminotadalafil, or the analog of sildenafil, an active ingredient of another FDA-approved ED drug, making these products unapproved drugs. The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Customers who have these products in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking these products. Read the 2009 MedWatch safety summary, including a link to the company's Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm172312.htm | 7/16/2009 10:50 AM | Shujin | | | Concentrated Acetaminophen Drops | Brookstone Pharmaceuticals and FDA notified healthcare professionals and consumers of a nationwide voluntary recall of all lots of Concentrated Acetaminophen Drops (NDC#42192-504-16) in 16 ounce (473 ml) bulk containers. The recalled drops were manufactured by Pharmaceutical Associates, Inc. This 16oz container is comparable to the size generally used to package regular strength acetaminophen liquid preparations. This aspect of the product coupled with the absence of an integrated dosage delivery device is a contributing factor to possible dosing errors, especially inadvertent overdosing. Over dosage of acetaminophen may result in liver toxicity, kidney damage, and blood disorders. The firm is recalling its product to the consumer level as a cautionary measure to minimize any confusion and potential risk to patients from dosing errors. Read the MedWatch safety summary, including a link to the Brookstone Pharmaceuticals press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm172252.htm | 7/15/2009 9:10 PM | Shujin | | | Libipower Plus (recall) | Haloteco and FDA notified healthcare professionals and consumers of a nationwide voluntary recall of Libipower Plus. Lab analysis of Libipower Plus samples were found to contain undeclared Tadalalafil, an active ingredient of FDA approved drugs for Erectile Dysfunction (ED). Tadalalafil may interact with nitrates found in some prescription drugs such as nitroglycerin, and may lower blood pressure to dangerous levels. Additionally, the product may cause side effects, such as headaches and flushing. Libipower Plus is sold as a 1 capsule blister pack through distributors and retail stores in California. Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. Read the complete MedWatch safety summary, including a link to the Haloteco Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171914.htm | 7/15/2009 9:25 AM | Shujin | | | Rapamune, Sandimmune, Neoral, Cellcept, Myfortic, and generics | Sirolimus (marketed as Rapamune), Cyclosporine (marketed as Sandimmune and generics), Cyclosporine modified (marketed as Neoral and generics), Mycophenolate mofetil (marketed as Cellcept and generics), Mycophenolic acid (marketed as Myfortic)
Audience: Transplant and nephrology healthcare professionals
The FDA is requiring the makers of certain immunosuppressant drugs to update their labeling to reflect that immunosuppressed patients are at increased risk for opportunistic infections, such as activation of latent viral infections, including BK virus-associated nephropathy. These immunosuppressant drugs are used to protect against the rejection of certain organ transplants. The association of BK virus-associated nephropathy has previously been reported for another immunosuppressant drug, tacrolimus (marketed as Prograf). Monitoring for this serious risk and early intervention by the health care provider is critical. Adjustments in immunosuppression therapy should be considered for patients who develop BK virus-associated nephropathy. Read the MedWatch safety summary, including a link to the FDA "Information for Healthcare Professionals" page, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171828.htm | 7/14/2009 8:55 PM | Shujin | | | Medtronic Paradigm Quick-Set Infusion Sets | Medtronic Paradigm Quick-Set Infusion Sets
Audience: Diabetes healthcare professionals, patients
Medtronic, Inc. and FDA notified healthcare professionals and patients of a recall of Quick-set infusion sets that are used with MiniMed Paradigm insulin pumps because the affected infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may lead to serious injury or death. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days. Affected infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number “8". Patients should discontinue using “Lot 8” Quick-set infusion sets. The lot number (for example 8XXXXXX) is clearly marked on both the product box label, and on each individual infusion set package. Customers are being asked to return any affected infusion sets to the company. Read the complete MedWatch Safety summary, including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171686.htm | 7/13/2009 11:05 PM | Shujin | | | Mallinckrodt Sodium Chromate Cr-51 Injection | Mallinckrodt Sodium Chromate Cr-51 Injection
Audience: Hematology and Nuclear Medical healthcare professionals, hospital risk managers
Covidien and FDA announced the recall of one lot [#370-9004] of Mallinckrodt Sodium Chromate Cr-51 Injection as a result of routine post-market testing in which the product was found to be subpotent. Sodium Chromate Cr-51 Injection is a radiopharmaceutical agent used in a diagnostic test to determine the presence of a disease known as Polycythemia rubra vera. Using subpotent product could lead to an incorrect test result. A misdiagnosis or delayed diagnosis followed by a delay in treatment puts patients at an increased risk of embolus or stroke. This recall is being conducted to inform healthcare providers of the potential for a false low reading of red blood cell volume and to prevent further use of the product. Customers who have product from the recalled lot in their possession should discontinue use immediately. Customers with questions about the recalled product, including returns, should contact Product Monitoring at 800-778-7898 (7:00 am to 5:00 pm CT). Read the complete MedWatch 2009 Safety summary, including a link to the Covidien press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171396.htm | 7/10/2009 9:25 PM | Shujin | | | Stealth Chocolate, Stealth Vanilla Powdered Dietary Supplement | Stealth Chocolate, Stealth Vanilla Powdered Dietary Supplement: Vital Pharmaceuticals Inc
Audience: Consumers, healthcare professionals
Vital Pharmaceuticals Inc. and FDA notified healthcare professionals and consumers of a nationwide recall of the powdered dietary supplement, Stealth Chocolate and Stealth Vanilla, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. The product was distributed nationwide, including GNC Distribution Centers, VPX Sports Distribution Center, and internationally. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. Consumers should return the product to the store where it was purchased. Read the complete MedWatch 2009 Safety summary, including a link to the firm press release, at: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171231.htm | 7/9/2009 11:30 PM | Shujin | | | BiPAP Focus Non-Invasive Ventilator System | BiPAP Focus Non-Invasive Ventilator System, Respironics California
Audience: Respiratory healthcare professionals, risk managers
Respironics California, Inc. and FDA notified healthcare professionals of a Class I recall of the BiPAP Focus Non-Invasive Ventilator System, model number PCM120PS18-2315P. Power supply failures have occurred on some ventilators. This product was distributed from August, 2006 through April 11, 2008. Customers/distributors may contact Respironics U.S. Customer Service at 1-877-387-3377 or Respironics International Customer Service at 1-724-387-4000. Read the complete MedWatch Safety summary, including a link to the FDA Recall notice, at: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171242.htm | 7/9/2009 11:25 PM | Shujin | | | Products containing Propoxyphene | Propoxyphene-containing Products
Audience: Pharmacists, Pain management healthcare professionals
FDA notified healthcare professionals that it is taking several actions to reduce the risk of overdose in patients using pain medications that contain propoxyphene because of data linking propoxyphene and fatal overdoses. The agency will require manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products and to provide a medication guide to patients stressing the importance of using the drugs as directed. FDA is requiring a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses. Findings from this study, as well as other data, could lead to additional regulatory action. To further evaluate the safety of propoxyphene, FDA plans to work with several groups including the Centers for Medicare & Medicaid Services and the Veterans Health Administration to study how often the elderly are prescribed propoxyphene instead of other pain relievers and the difference in the safety profiles of propoxyphene compared to other drugs. Read the complete MedWatch Safety summary, including links to the FDA news release and Q&A's, at: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170763.htm | 7/7/2009 4:20 PM | Shujin | | | Arthroscopic Shavers | Arthroscopic Shavers: Ongoing Safety Review
Audience: Orthopedic healthcare professionals, hospital risk managers, surgical services supervisors
FDA informed healthcare professionals of instances in which pieces of tissue have remained within arthroscopic shavers, a device used in orthopedic surgical procedures, even after the cleaning process was believed to have been completed according to the manufacturer’s instructions. Since retained tissue in these devices can compromise the entire sterilization process, FDA is actively working with the manufacturers of these devices to gather more data about this situation and to understand its potential public health impact. FDA encourages facilities that use any of these types of devices to evaluate the adequacy of their cleaning procedures and has provided recommendations for minimizing the potential risk to patients. FDA asks that surgical facilities that discover retained tissue in arthroscopic shavers after following the manufacturer-recommended cleaning procedures file a voluntary report with MedWatch, the FDA Safety Information and Adverse Event Reporting program online. These voluntary reports will help FDA gather additional information related to this problem and assess its public health impact. Read the complete MedWatch 2009 Safety summary, including a link to the FDA communication about the ongoing safety review, at: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170730.htm | 7/7/2009 4:15 PM | Shujin | | | Varenicline (Chantix) and Bupropion (Zyban, Wellbutrin, generics) | Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics)
Audience: Neuropsychiatric healthcare professionals, patients
FDA notified healthcare professionals and patients that it has required the manufacturers of the smoking cessation aids varenicline (Chantix) and bupropion (Zyban and generics) to add new Boxed Warnings and develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms in patients using these products.These symptoms include changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide.The added warnings are based on the continued review of postmarketing adverse event reports for varenicline and bupropion received by the FDA. These reports included those with a temporal relationship between the use of varenicline or bupropion and suicidal events and the occurrence of suicidal ideation and suicidal behavior in patients with no history of psychiatric disease. Healthcare professionals should advise patients to stop taking varenicline or bupropion and contact a healthcare provider immediately if they experience agitation, depressed mood, and any changes in behavior that are not typical of nicotine withdrawal, or if they experience suicidal thoughts or behavior. Read the complete MedWatch 2009 Safety summary, including links to the FDA Public Health Advisory, Information for Healthcare Professionals and previous MedWatch alerts, at: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170090.htm | 7/1/2009 2:50 PM | Shujin | | | Lantus (insulin glargine) | Lantus (insulin glargine)
Audience - Diabetes healthcare professionals, patients
FDA notified healthcare professionals and patients that it is aware of four recently-published observational studies that looked at the use of Lantus (insulin glargine) and possible risk for cancer in patients with diabetes. Three of the four studies suggest an increased risk for cancer associated with use of Lantus. Based on the currently available data, the FDA recommends that patients should not stop taking their insulin therapy without consulting a physician, since uncontrolled blood sugar levels can have both immediate and long-term serious adverse effects. FDA is currently reviewing many sources of safety data for Lantus, including these newly published observational studies, data from all completed controlled clinical trials, and information about ongoing controlled clinical trials, to better understand the risk, if any, for cancer associated with use of Lantus. Discussions are also ongoing between FDA and the manufacturer of Lantus as to whether any additional studies evaluating the safety and efficacy of this drug will need to be performed. FDA will communicate the results on its ongoing review to the public, as appropriate, as our review continues. The FDA encourages both healthcare professionals and patients to report side effects from the use of insulin glargine to the FDA's MedWatch Adverse Event Reporting Program at www.fda.gov/medwatch/report.htm. Read the complete MedWatch Safety summary, including a link to the Early Communication and supporting documents, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170089.htm | 7/1/2009 2:40 PM | Shujin | | | Cefepime (marketed as Maxipime) Update of Ongoing Safety Review |
Cefepime (marketed as Maxipime) Update of Ongoing Safety Review
Audience: Infectious disease healthcare professionals FDA notified healthcare professionals that it has finished its analysis of a possible risk of higher death with cefepime, an antibiotic, following publication of a study that suggested a higher rate of death in patients treated with this drug, as compared to patients treated with similar drugs. FDA reviewed this study data and conducted additional analyses based on additional data, including data submitted by Bristol Meyers Squibb. FDA has determined that the data do not indicate a higher rate of death in cefepime-treated patients. Cefepime remains an appropriate therapy for its approved indications. FDA will continue to review the safety of cefepime. As part of this ongoing review, both FDA and Bristol Meyers Squib are conducting separate analyses of death potentially associated with cefepime, using hospital drug use data. The results of these analyse s likely will be reported in approximately one year. Read the complete MedWatch 2009 Safety Summary, including links to the Update of Ongoing Safety Review and previous 2007 and 2008 MedWatch safety alerts, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm167427.htm | 6/21/2009 7:05 AM | Shujin | | | Zicam Cold Remedy Nasal Products |
Zicam Cold Remedy Nasal Products (Cold Remedy Nasal Gel, Cold Remedy Nasal Swabs, and Cold Remedy Swabs, Kids Size)
Audience: Consumers FDA notified consumers and healthcare professionals to discontinue use of three Zicam Nasal Gel/Nasal Swab products sold over-the-counter as cold remedies because they are associated with the loss of sense of smell that may be long-lasting or permanent. The FDA has received more than 130 reports of loss of sense of smell associated with the use of the three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products. People who have experienced a loss of sense of smell or other problems after use of the affected Zicam products should contact their health care professional. The loss of sense of smell can adversely affect a person’s quality of life, and can limit the ability to detect the smell of gas or smoke or other signs of danger in the environment. Read the complete MedWatch 2009 Safety Summary, including links to the Public Health Advisory and Consumer Update page, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166996.htm | 6/21/2009 7:05 AM | Shujin | | | Stamina-Rx Dietary Supplement Products | Stamina-Rx Dietary Supplement Products
Audience: Consumers
FDA and Hi-Tech Pharmaceuticals notified patients and healthcare professionals of a nationwide recall of all products sold under the name Stamina-Rx. FDA lab analysis found that the product contained the undeclared ingredient − benzamidenafil − a drug in the same therapeutic class of active pharmaceutical ingredients that include the PDE5 inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction. Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be most susceptible to adverse effects from this product. Stamina-Rx is sold predominantly in health food and drug stores nationwide. Consumers who have this product in thei r possession should stop using it immediately. Read the complete MedWatch Safety summary, including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm168017.htm | 6/21/2009 7:00 AM | Shujin | | | Nestle Toll House Prepackaged, Refrigerated Cookie Dough | Nestle Toll House Prepackaged, Refrigerated Cookie Dough
Audience: Consumers, All Healthcare Professionals
FDA and the CDC are warning consumers not to eat any varieties of prepackaged Nestle Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes food borne illness). The warning is based on an ongoing epidemiological study conducted by the CDC and several state and local health departments. Since March 2009 there have been 66 reports of illness across 28 states. Twenty-five persons were hospitalized; 7 with a severe complication called Hemolytic Uremic Syndrome (HUS). No one has died. E.coli O157:H7 causes abdominal cramping, vomiting and a diarrheal illness, often with bloody stools. Most healthy adults can re cover completely within a week. Young children and the elderly are at highest risk for developing HUS, which can lead to serious kidney damage and even death. FDA advises that if consumers have any prepackaged, refrigerated Nestle Toll House cookie dough products in their home that they throw them away. Cooking the dough is not recommended because consumers might get the bacteria on their hands and on other cooking surfaces. Individuals who have recently eaten prepackaged, refrigerated Toll House cookie dough and have experienced any of these symptoms should contact their doctor or health care provider immediately. Any such illnesses should be reported to state or local health authorities. Read the complete MedWatch 2009 Safety summary including links to the FDA news release and consumer update and the CDC information page, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm168005.htm | 6/21/2009 6:55 AM | Shujin | | | Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder |
Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder
Products involved include: Focalin, Focalin XR (dexmethylphenidate HCl ); Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat (dextroamphetamine sulfate); Vyvanse (lisdexamfetamine dimesylate); Desoxyn (methamphetamine); Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR (methylphenidate); Adderall, Adderall XR (mixed salts amphetamine); Cylert (pemoline) and generics.
Audience: Pediatricians, Neuropsychiatric healthcare professionals
FDA notified healthcare professionals that it is providing its perspective on study data published in the American Journal of Psychiatry on the potential risks of stimulant medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children. This study, funded by the FDA and the National Institute of Mental Health (NIMH), compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly to the use of stimulant medications in 564 children who died as passengers in a motor vehicle accident.The study authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children. Given the limitations of this study’s methodology, the FDA is unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. FDA believes that this stud y should not serve as a basis for parents to stop a child’s stimulant medication. Parents should discuss concerns about the use of these medicines with the prescribing healthcare professional. Any child who develops cardiovascular symptoms (such as chest pain, shortness of breath or fainting) during stimulant medication treatment should immediately be seen by a doctor.
FDA is continuing its review of the strengths and limitations of this and other epidemiological studies that evaluate the risks of stimulant medications used to treat ADHD in children. FDA and the Agency for Healthcare Research and Quality are sponsoring a large epidemiological study that will provide further information about the potential risks associated with stimulant medication use in children. The data collection for this study will be complete later in 2009. Read the complete MedWatch 2009 Safety Summary, including a link to the Communication and the FDA News Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166667.htm | 6/16/2009 4:45 AM | Shujin | | | Medtronic Kappa Series 600/700/900 | Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers
Audience: Cardiology healthcare professionals
Medtronic and FDA notified healthcare professionals and patients of a Class I recall of Medtronic Kappa Series 600/700/900 and Sigma Series 100/200/300 pacemakers due to a failure of the devices to pace the heart. Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. In rare cases, pacemaker-dependent patients may experience serious injury or even death. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. Most of the pacemakers affected by this recall have been implanted in patients for five years or longer. To determine if a pacemaker is part of this recall, contact Medtronic at 1-800-505-4636. Read the complete MedWatch 2009 Safety Summary, including links to the FDA news release, recall notice and consumer information, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm165711.htm | 6/13/2009 10:45 PM | Shujin | | | Levemir Insulin (Novo Nordisk) | Levemir Insulin (Novo Nordisk)
Audience: Patients, pharmacists, diabetes healthcare professionals
FDA notified patients and healthcare professionals that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. are being sold in the U.S. market, may not have been stored and handled properly, and may be dangerous for patients to use. The agency is advising patients who use Levemir insulin to:
- Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036, XZF0037, and XZF0038.
- Do not use your Levemir insulin if it is from one of these lots.
- Always visually inspect your insulin before using it. Levemir is a clear and colorless solution.
- Contact the Novo Nordisk Customer Care Center at 1-800-727-6500 for what to do with vials from these lots or if you have any other questions.
Read the complete MedWatch 2009 Safety Summary, including a link to the FDA News Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166359.htm | 6/13/2009 10:40 PM | Shujin | | | Sirolimus (marketed as Rapamune) |
Sirolimus (marketed as Rapamune)
Audience: Transplantation healthcare professionals FDA notified healthcare professionals of clinical trial data that suggest increased mortality in stable liver transplant patients after conversion from a calcineurin inhibitor (CNI)-based immunosuppressive regimen to sirolimus (Rapamune). The trial was conducted by sirolimus manufacturer, Wyeth. The Agency will continue to examine the data on mortality and other adverse events in this study, and will make further recommendations, as appropriate. The FDA is determining whether a labeling change for sirolimus is needed. In the interim, physicians should continue to use the drug’s professional labeling as a guide to therapy. See the FDA Healthcare Professional Information sheet for current FDA recommendations. Read the complete MedWatch 2009 Safety summary, including a link to the FDA Healthcare Professional Information Sheet, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm165731.htm | 6/11/2009 12:45 PM | Shujin | | | Clarcon skin sanitizers and skin protectants |
Skin Products Made by Clarcon
Audience: Consumers, pharmacists, all healthcare professionals
FDA notified consumers and healthcare professionals that Clarcon Biological Chemistry Laboratory is recalling some skin sanitizers and skin protectants because of high levels of disease-causing bacteria found in the product. During an FDA inspection, analyses of samples of several of these products revealed high levels of various bacteria, including some associated with unsanitary conditions. Some of these bacteria can cause opportunistic infections of the skin and underlying tissues. Such infections may need medical or surgical attention, and may result in permanent damage. These findings are particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds, damaged skin, and protect against various infectious diseases. FDA is warning consumers to not use any Clarcon products and should throw these produ cts away in household refuse.
Read the complete MedWatch 2009 Safety summary, including a link to the FDA News Release, at:
| 6/9/2009 3:50 PM | Shujin | | | Propylthiouracil (PTU) | Propylthiouracil (PTU)
Audience: Endocrine healthcare professionals, Pharmacists, Pediatricians
FDA notified healthcare professionals of the risk of serious liver injury, including liver failure and death, with the use of propylthiouracil (PTU) in adult and pediatric patients. Reports to FDA’s Adverse Event Reporting System (AERS) suggest there is an increased risk of hepatotoxicity with PTU when compared to methimazole (MMI). FDA has identified 32 (AERS) cases (22 adult and 10 pediatric) of serious liver injury associated with PTU use. Although both PTU and MMI are indicated for the treatment of hyperthyroidism due to Graves’ disease, healthcare professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease. Physicians should closely monitor patients on PTU therapy for symptoms and signs of liver injury, especially during the first six months after initiation of therapy. PTU should not be used in pediatric patients unless the patient is allergic to or intolerant of MMI, and there a re no other treatment options available. Read the MedWatch 2009 safety alert, including a link to the FDA Healthcare Professional Sheet, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm164162.htm | 6/3/2009 4:00 PM | Shujin | | | Simponi (golimumab) |
Simponi (golimumab)
Audience: Rheumatological healthcare professionals
Centocor Ortho Biotech and FDA reminded healthcare professionals of the risk of serious fungal infections associated with TNF-αlpha blockers, including Simponi [golimumab]. FDA has reported that histoplasmosis and other invasive fungal infections are not consistently recognized in patients taking other TNF-αlpha blockers including Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab). This has resulted in delays in appropriate antifungal treatment, sometimes even resulting in death. It is important that all adverse events potentially associated with Simponi be reported so that the adverse event profile reported in the prescribing information can be updated appropriately as post-approval experience is gathered. Centocor encourages reporting adverse events to Centocor at 1-800-457-6399 or to the FDA MedWatch program at 1-800-332-1088. Read the complete MedWatch 2009 Safety summary, including links to the Dear Healthcare Professional letter, Prescribing Information, Medication Guide and previous 2008 MedWatch alert, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Simponi | 5/28/2009 8:45 PM | Shujin | | | SmartMonitor 2 Infant Apnea Monitor |
Respironics, Inc. SmartMonitor 2 Infant Apnea Monitor, Models 4002 and 4003
Audience: Consumers, Pediatricians
Respironics and FDA notified healthcare professionals of a Class I recall of SmartMonitor 2 Infant Apnea Monitor, Models 4002 and 4003, used for the continuous monitoring of respiration and heart rate of infant patients in the home or in the hospital. The monitors may fail to sound an alarm during periods of temporary interruption of breathing or low heart rates. The affected products were manufactured from January 16, 2008 through November 13, 2008 and distributed from January 17, 2008 through December 31, 2008. Read the complete MedWatch 2009 Safety summary, including a link to the FDA recall notice, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#SmartMonitor | 5/18/2009 2:25 AM | Shujin | | | Digoxin |
Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand)
Audience: Pharmacists, cardiology healthcare professionals, consumers
[UPDATED 05/12/2009] AS Medication Solutions, LLC, a drug repackage company, announced today that all tablets of Caraco brand Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of August, 2011, are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. Caraco Pharmaceutical Laboratories, Ltd manufactured the recalled tablets. The recalled product is a scored round biconvex white tablet imprinted with “441”, with an NDC number of 54569-5758-0 (30-count). Consumers with the product that are within expiration should return these products to their pharmacy or place of purchase. Read the complete MedWatch 2009 Safety summary, including a link to the original April 1 alert and the current firm press release, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Digoxin | 5/12/2009 5:15 PM | Shujin | | | Fun Express Water-based Face Paints for Children (Recall) |
Fun Express Water-based Face Paints for Children
Audience: Consumers, Pediatricians, Dermatologists
FDA is notifying consumers and healthcare professionals of the recall of cosmetic “Face Paint” items labeled as distributed by Oriental Trading Co., Omaha, Neb., due to adverse event reports of skin reactions in children, including rashes, itchiness, burning sensation, and swelling where the face paints were applied. All exposures occurred on the same day at an organized event in children exposed to various colors of the face paint. Significant microbial contamination was indicated in most of the products in testing by an FDA laboratory. These items were distributed nationwide. See the News Release for a listing of affected products. Read the complete MedWatch 2009 Safety summary, including a link to the FDA news release, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Paints | 5/12/2009 3:35 PM | Shujin | | | Tarceva (erlotinib) |
Tarceva (erlotinib)
Audience: Oncological, dermatological and ophthalmological healthcare professionals
OSI, Genentech and FDA notified healthcare professionals of new safety information added to the WARNINGS AND PRECAUTIONS sections of the prescribing information for Tarceva. Gastrointestinal perforation (including fatalities), bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular disorders, including corneal perforation or ulceration have been reported during use of Tarceva. The new safety information comes from routine pharmacovigilance activities of clinical study and postmarketing reports. Tarceva monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. In combination with gemcitabine, Tarceva is also indicated for the first-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer. Read the complete MedWatch 2009 Safety summary, including a link to the OSI Dear Healthcare Professional Letter, at:`http://www.fda.gov/medwatch/safety/2009/safety09.htm#Tarceva | 5/8/2009 5:35 PM | Shujin | | | Biosite brand Triage Cardiac Panel (Recall) |
Biosite brand Triage Cardiac Panel
Audience: Emergency care managers, hospital risk managers, laboratory services managers
Biosite and FDA notified healthcare professionals of the Class 1 recall of the Biosite brand Triage Cardiac Panel, a test is used by health professionals as an aid in the diagnosis of a heart attack (myocardial infarction).The use of the affected lot may lead to false negative results with patient samples containing troponin I at very low levels, with CK-MB, and with myoglobin, possibly resulting in missed or incorrect diagnosis. A false negative test result would indicate that a person has not had a heart attack or heart muscle injury when in fact they have. Lot #W44467B, shipped as 25 individually pouched devices per kit box, was distributed from January 24, 2009 through February 17, 2009. On April 27, 2009, the company sent an urgent recall notice to customers who were instructed to immediately discontinue all use of, and to discard, all affected products. Read the complete MedWatch 2009 Safety summary, including a link to the FDA recall notice, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Panel | 5/8/2009 5:30 PM | Shujin | | | Anti-epileptic Drugs |
Antiepileptic Drugs
Audience: Neuropsychiatric healthcare professionals, other healthcare professionals, patients
FDA notified healthcare professionals that it approved updated labeling for antiepileptic drugs used to treat epilepsy, psychiatric disorders, and other conditions (e.g., migraine and neuropathic pain syndromes). FDA also required development of a medication guide, to be issued to patients each time the product is dispensed. Since issuing safety alerts on December 16, 2008 and January 31, 2008, FDA has been working with the manufacturers of drugs in this class to better understand the suicidality risk. Eleven antiepileptic drugs were included in a pooled analysis of placebo-controlled clinical studies in which these drugs were used to treat epilepsy as well as psychiatric disorders and other conditions. The increased risk of suicidal thoughts or behavior was generally consistent among the eleven drugs, with varying mechanisms of action and across a range of indications. This observation suggests that the risk applies to all antiepileptic drugs used for any indi cation. Read the complete MedWatch 2009 Safety summary, including a link to the updated Healthcare Professional sheet, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic | 5/5/2009 4:05 PM | Shujin | | | Hydroxycut Products (dietary supplements) Serious liver risks |
Hydroxycut Products
Audience: Consumers, healthcare professionals
[Posted 05/01/2009] FDA warned consumers to immediately stop using Hydroxycut products by Iovate Health Sciences, Inc. Hydroxycut products are associated with a number of serious liver injuries. Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names. FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects. Read the complete MedWatch Safety summary including links to the FDA news release, Q&A's and a listing of all products included in this alert, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Hydroxycut | 5/1/2009 12:50 PM | Shujin | | | ACCU-CHEK Spirit Insulin Pump |
Disetronic Medical Systems Inc. ACCU-CHEK Spirit Insulin Pump
Audience: Diabetes healthcare professionals, patients
Disetronic Medical Systems Inc. and FDA notified healthcare professionals about a defect in the “up” and/or “down” buttons of some ACCU-CHEK Spirit insulin pumps. This failure may present as an intermittent or complete loss of function of the “up” and/or “down” buttons. If the buttons do not function, users may not be able to change any programmed setting on the pump. If this failure occurs, the pump may not respond with a vibration or acoustic confirmation signal to a button press and the display will remain unchanged. Users may contact ACCU-CHEK Spirit hotline noted in the Press Release for a replacement pump or for any other questions regarding this potential defect. Read the complete MedWatch 2009 Safety summary, including a link to the firm's press release, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Spirit | 5/1/2009 12:45 PM | Shujin | | | Botox and Botox Cosmetic (Boxed Warning required) |
FDA notified healthcare professionals that after an ongoing safety review initiated in February 2008, the manufacturers of licensed botulinum toxin products will be required by FDA to strengthen warnings in product labeling and add a boxed warning regarding the risk of adverse events when the effects of the toxin spread beyond the site where it was injected. FDA will also require that manufacturers develop and implement a Risk Evaluation and Mitigation Strategy [REMS], including a communication plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged. The REMS would also include a Medication Guide that explains the risks to patients, their families, and caregivers. FDA is requiring the manufacturers to submit safety data after multiple administrations of the product in a specified number of children and adults with spasticity to assess the signal of serious risk regarding distant spread of toxin effects. FDA’s evaluation of the data continues to support the recommendations made in the 2008 Early Communication. Read the MedWatch safety summary, including a link to the Communication about Botox, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Botox | 4/30/2009 5:05 PM | Shujin | | | Botox (botulinum toxin) products (Strengthened Warnings) | FDA notified healthcare professionals that after an ongoing safety review initiated in February 2008, the manufacturers of licensed botulinum toxin products will be required by FDA to strengthen warnings in product labeling and add a boxed warning regarding the risk of adverse events when the effects of the toxin spread beyond the site where it was injected. FDA will also require that manufacturers develop and implement a Risk Evaluation and Mitigation Strategy [REMS], including a communication plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged. The REMS would also include a Medication Guide that explains the risks to patients, their families, and caregivers. FDA is requiring the manufacturers to submit safety data after multiple administrations of the product in a specified number of children and adults with spasticity to assess the signal of serious risk regarding distant spread of toxin effects. FDA’s evaluation of the data continues to support the recommendations made in the 2008 Early Communication. | 4/30/2009 2:15 PM | Shujin | | | Libimax, sold as a Dietary Supplement Product |
Libimax, sold as a Dietary Supplement Product
Audience: Consumers, pharmacists
Nature & Health Co. and FDA notified healthcare professionals of a recall of a supplement product, Libimax. FDA analysis found the product contains tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction. This product poses a threat to health because tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers who have Libimax in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product. Read the complete MedWatch 2009 Safety summary, including a link to the firm's press release, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Libimax | 4/29/2009 5:55 PM | Shujin | | | Personal Care Non-Acetone Nail Polish Remover |
Personal Care Non-Acetone Nail Polish Remover
Audience: Dermatologists, ER healthcare professionals
Personal Care Products and FDA notified healthcare professionals of a voluntarily nationwide recall of all lots of Personal Care non-acetone nail polish remover, conditioner enriched with gelatin, 6 fl. oz., UPC 4815592076, because it has the potential to cause chemical burns to the fingers of users. Read the complete MedWatch 2009 Safety summary, including a link to the firm's press release and photo of the product, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Nail | 4/29/2009 2:45 PM | Shujin | | | Dietary Supplements Distributed by Universal ABC Beauty Supply (Recall) |
Dietary Supplements Distributed by Universal ABC Beauty Supply International, Inc.
Audience: Consumers, pharmacists
ABC Beauty Supply and FDA notified consumers and healthcare professionals of a recall of 34 dietary supplement products. FDA lab analyses identified undeclared sibutramine, an FDA-approved drug, used as an appetite suppressant for weight loss. FDA advises that these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. See the firm's press release for a list of affected products. Read the complete MedWatch Safety Summary, including a link to the firm press release, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#ABC | 4/24/2009 8:10 AM | Shujin | | | all Influend Cough and Cold products (Recall) |
Influend Cough and Cold Products
Audience: Pharmacists, consumers
ION Labs and FDA notified consumers and healthcare professionals of the recall of all Influend Cough and Cold products sold on or after May 30, 2008 due to the possibility that the products may be superpotent with possible complications ranging from tachycardia, palpitations, arrhythmias, and cardiovascular collapse with hypotension to headaches, dizziness, anxiety, restlessness and nervousness. Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. Read the complete MedWatch 2009 Safety Summary, including a link to the firm's press release, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Influend | 4/16/2009 6:40 PM | Shujin | | | Aortic Balloon Pump (IAB) Catheters |
Arrow International 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters
Audience: Cardiology and cardiovascular healthcare professionals, hospital risk managers
Teleflex Medical and FDA notified healthcare professionals of the Class 1 recall for Arrow International 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters, a component of the Intra-Aortic Pump System which is designed to provide cardiac assist therapy to critically ill people to increase blood flow to the heart. This recall is being conducted because a fault in the connector of the pump tubing assembly may result in failure of the system to decrease ischemia and increase perfusion, leading to organ injury or infarct and may result in patient death. Prolonged exposure could also result in thrombus formation on the IAB and possible subsequent systemic or cerebral thromboembolism. Read the complete MedWatch Safety Summary, including a link to the FDA recall notice, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Arrow | 4/15/2009 4:50 PM | Shujin | | | Ceftriaxone (marketed as Rocephin and generics) | Ceftriaxone (marketed as Rocephin and generics)
Audience: Neonatology, infectious disease healthcare professionals, hospital risk managers
FDA notified healthcare professionals of an update to a previous alert that addresses the interaction of ceftriaxone with calcium-containing products, based on previously reported fatal cases in neonates. At the request of FDA, the manufacturer of ceftriaxone (Roche) conducted two in vitro studies to assess the potential for precipitation of ceftriaxone-calcium when ceftriaxone and calcium-containing products are mixed in vials and in infusion lines. These two in vitro studies were conducted in neonatal and adult plasma to assess the potential for precipitation of ceftriaxone-calcium using varying ceftriaxone and calcium concentrations, including concentrations in excess of those achieved in vivo. Based on the results from these studies, FDA now recommends that ceftriaxone and calcium-containing products may be used concomitantly in patients >28 days of age, using the precautionary recommendations noted because the risk of precipitation is low in this population. F DA had previously recommended, but no longer recommends, that in all age groups ceftriaxone and calcium-containing products should not be administered within 48 hours of one another. Read the complete MedWatch 2009 Safety Summary, including a link to the updated Healthcare Professional Sheet, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Ceftriaxone
| 4/14/2009 11:10 AM | Shujin | | | ZOLL AED Plus Defibrillator (Recall) |
ZOLL AED Plus Defibrillator
Audience: Emergency medical personnel
ZOLL Medical Corporation and FDA notified healthcare professionals of a Class 1 recall of ZOLL AED Plus Defibrillators distributed from May, 2004 through February 9, 2009. The recall was initiated because the device may fail to deliver a defibrillation shock, which could result in failure to resuscitate a patient during treatment of sudden cardiac arrest. On February 12 and March 31, 2009, the company sent their distributors and customers recall letters with recommendations and instructions for customers on specific steps to mitigate the identified problems with this device. See the Zoll letter at link below for details. Read the complete MedWatch 2009 Safety Summary, including links to the FDA notice and the Zoll customer letter at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#ZOLLAEDplus | 4/9/2009 1:55 PM | Shujin | | | Raptiva (efalizumab) (Market Withdrawal) |
Raptiva (efalizumab)
Audience: Dermatological healthcare professionals, patients Genentech and FDA notified healthcare professionals of the voluntary, phased withdrawal of Raptiva, a medication for treatment of psoriasis, from the U.S. market due to a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML). By June 8, 2009, Raptiva will no longer be available in the United States. Prescribers are being asked not to initiate Raptiva treatment for any new patients. Prescribers should immediately begin discussing with patients currently using Raptiva how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to alternative therapies for psoriasis. Read the complete MedWatch 2009 Safety Summary, including links to the Dear Healthcare Professional letter, the Dear Patient letter and the FDA statement, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Raptiva | 4/9/2009 12:05 AM | Shujin | | | Caraco brand Digoxin |
Caraco Pharmaceutical Laboratories and FDA notified healthcare professionals of a consumer-level recall of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin, a drug product used to treat heart failure and abnormal heart rhythms. The drug has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Consumers with the recalled product should return these products to their pharmacy or place of purchase. Read the MedWatch safety summary, including a link to the company Press Release, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Digoxin | 4/1/2009 5:45 PM | Shujin | | | Innervision (recall) |
Medtronic and FDA notified healthcare professionals about a Class I recall of the Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide due to the possibility that the ventricular catheter may become detached from the snap base assembly after implantation and may require emergency corrective surgery. The ventricular catheters are part of a surgically implanted system that redirects excess fluid from the brain to another part of the body. The recalled product was distributed from April 29, 2004 through December 12, 2008. Patients with questions are encouraged to talk with their physicians. Medtronic sent their customers a recall notice on February 13, 2009 informing them that they should stop using the device, are required to account for each used (implanted) device, are to advise surgeons about the recall, and need to return all unused products to the company. Read the MedWatch safety summary, including a link to the recall notice, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Innervision | 3/27/2009 7:10 PM | Shujin | | | Propafenone HCL recall |
FDA and Watson Pharmaceuticals notified healthcare professionals and patients of a recall of Propafenone HCL 225 mg tablets, a drug product used to treat cardiac arrhythmias. The drug is being recalled because some tablets may contain slightly higher levels of the active ingredient than specified. Because it has a narrow therapeutic index, some patients who are particularly sensitive to small variations in dose may experience potentially serious side effects, including arrhythmias (irregular heartbeat) or low blood pressure. The affected lot [lot number 112680A, expiration date July 31, 2010] of Propafenone HCL tablets was shipped to customers between October 15, 2008 and November 26, 2008. The Press Release includes instructions for identifying and returning the affected product.
Read the MedWatch safety summary, including a link to the company Press Release, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Propafenone | 3/25/2009 10:40 AM | Shujin | | | Weight loss products |
(UPDATE) FDA expanded its nationwide alert to consumers about tainted weight loss products containing undeclared, active pharmaceutical ingredients. The FDA has identified additional weight loss products (Herbal Xenicol, Slimbionic, and Xsvelten) and new undeclared active pharmaceutical ingredients (fenproporex, fluoxetine, furosemide, and cetilistat). The current list now includes 72 products.
Read the MedWatch safety summary, including an updated link to the FDA News Release, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Weight | 3/23/2009 11:55 AM | Shujin | | | Zencore Plus (Recall) |
Bodee LLC and FDA notified consumers and healthcare professionals of a nationwide recall of all the company's supplement product sold under the name Zencore Plus. FDA lab analysis of Zencore Plus samples found the product contains benzamidenafil, an undeclared drug product and a PDE5 inhibitor. The use of Zencore Plus by an unsuspecting user of organic nitrates may pose a life-threatening risk of sudden and profound drop of blood pressure due to potential interaction between benzamidenafil and organic nitrates. Zencore Plus is sold in health food stores and by mail order on internet nationwide. Consumers who have this product in their possession should stop using it immediately. Read the MedWatch safety summary, including a link to the company's Press Release, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Zencore | 3/20/2009 3:00 PM | Shujin | | | Insulin pens and insulin cartridges |
The FDA notified healthcare providers and patients that insulin pens and insulin cartridges are never to be shared among patients. Sharing of insulin pens may result in transmission of hepatitis viruses, HIV, or other blood-borne pathogens. Insulin pens are not designed, and are not safe, for one pen to be used for more than one patient, even if needles are changed between patients because any blood contamination of the pen reservoir could result in transmission of already existing blood-borne pathogens from the previous user. The FDA is working with the Centers for Disease Control and Prevention, professional societies and healthcare organizations to reinforce patient and healthcare provider education about proper and safe use of insulin pens. Read the MedWatch 2009 safety summary, including links to the "Information for Healthcare Professionals" page and the FDA News Release, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Insulin | 3/19/2009 2:55 PM | Shujin | | | AED 10 and MRL JumpStart external defibrillators |
FDA and Welch Allen notified healthcare professionals and consumers of a nationwide Class I recall of 14,054 AED 10 and MRL JumpStart external defibrillators manufactured between October 3, 2002 and January 25, 2007. These devices may experience low energy shock, unexpected device shutdown, and/or susceptibility to electromagnetic noise interference. If such issues arise, it may prevent defibrillation of a patient in cardiac arrest and could lead to death. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death. See the Recall Notice for additional instructions and contact information. Read the MedWatch safety summary, including a link to the Recall Notice, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#AED10 | 3/17/2009 11:35 PM | Shujin | | | Colleague Single and Triple Channel Volumetric Infusion Pumps by Baxter recalled |
FDA notified healthcare professionals of a Class 1 Recall of model numbers Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161and 2M9163. These products were manufactured and distributed from February, 1997 through December, 2008. The company identified software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death. Baxter sent a letter to all of its customers, which included advice and instructions to institutions using the infusion pumps. Read the MedWatch 2009 safety summary, including a link to the Recall Notice, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Colleague | 3/12/2009 10:45 PM | Shujin | | | Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube: Class 1 Recall |
FDA notified healthcare professionals of a Class 1 Recall of specific lots due to complaints received about difficulty inserting: 1) the device used to place the tracheostomy tube into the windpipe (obturator), and/or 2) a suction tube (catheter) into the tracheostomy tube. This problem may require that the tracheostomy tube be removed and replaced. Healthcare professionals and hospitals should remove all remaining affected products from their inventory, and return them for replacement or credit. Read the MedWatch safety summary, including a link to the Recall Notice, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Shiley | 3/10/2009 11:05 AM | Shujin | | | Transdermal patches (including Salonpas) |
Including Salonpas. FDA notified healthcare professionals and patients that certain transdermal patches (medicated patches applied to the skin), containing aluminum or other metals in the backing of the patches, can overheat during an MRI scan and cause skin burns in the immediate area of the patch. FDA is in the process of reviewing the labeling and composition of all medicated patches to ensure that those made with materials containing metal provide a warning about the risk of burns to patients who wear the patches during an MRI scan. Until this review is complete, FDA recommends that healthcare professionals referring patients to have an MRI scan identify those patients who are wearing a patch before the patients have the MRI scan. The healthcare professional should advise these patients about the procedures for removing and disposing of the patch before the MRI scan, and replacing the patch after the MRI scan. MRI facilities should follow published safe practice recommenda tions concerning patients who are wearing patches. Read the MedWatch safety summary, including a link to the FDA Public Health Advisory, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Transdermal | 3/5/2009 12:35 PM | Shujin | | | Metoclopramide (incl Reglan products) |
FDA notified healthcare professionals that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken. These symptoms are rarely reversible and there is no known treatment. Metoclopramide is available in a variety of formulations including tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection. Manufacturers will be required to implement a risk evaluation and mitigation strategy [REMS] to ensure patients are provided with a medication guide that discusses this risk. Current product labeling warns of the risk of tardive dyskinesia with c hronic metoclopramide treatment. Read the MedWatch 2009 safety summary, including a link to the FDA News Release, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Metoclopramide | 2/27/2009 8:55 AM | Shujin | | | Zonisamide (marketed as Zonegran, and generics) |
FDA notified healthcare professionals that updated clinical data has determined that treatment with zonisamide, indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy, can cause metabolic acidosis in some patients. Patients with predisposing conditions or therapies may be at greater risk for developing metabolic acidosis and the risk of zonisamide-induced metabolic acidosis appears to be more frequent and severe in younger patients. FDA recommends that healthcare professionals measure serum bicarbonate before starting treatment and periodically during treatment with zonisamide, even in the absence of symptoms and is working with the makers of zonisamide to revise the product labeling to reflect this new safety information. The notification includes recommendations for healthcare providers, information for patients, and a data summary. Read the MedWatch 2009 safety summary, including a link to the "Information for Healthcare Professionals" sheet, at http://www.fda.gov/medwatch/safety/2009/safety09.htm#Zonisamide | 2/23/2009 4:20 PM | Shujin | | | Raptiva |
FDA issued a Public Health Advisory to notify healthcare professionals of three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva. In October 2008, the labeling for Raptiva was changed to highlight, in a Boxed Warning, the risks of life-threatening infections, including PML. In addition, FDA directed Genentech, the manufacturer of Raptiva, to develop a Risk Evaluation and Mitigation Strategy, or REMS, to ensure that patients receive risk information about Raptiva. The FDA is reviewing this latest information. The agency will take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits, that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML, and that health care professionals carefully monitor patients for the possible development of PML. The Public Health Advisory provides recommendations for h ealthcare providers and patients when treatment with this product is considered. Read the MedWatch safety summary, including links to the Public Health Advisory and News Release, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Raptiva | 2/21/2009 7:55 AM | Shujin | | | CellCept (mycophenolate mofetil) |
CellCept (mycophenolate mofetil)
Audience: Renal, cardiac, and hepatic transplantation healthcare professionals
FDA and Roche Laboratories notified healthcare professionals of the introduction of a CellCept Medication Guide to provide important safety information in language that patients can easily comprehend. FDA regulations require a pharmacist to distribute a copy of the Medication Guide to every patient who fills a CellCept prescription from this point forward. FDA has also required the introduction of a Medication Guide for mycophenolic acid, marketed as Myfortic by Novartis. Read the complete MedWatch 2009 Safety summary including links to the Dear Healthcare Professional and Dear Pharmacist letters, the new Medication Guide and the current Prescribing Information, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#CellCept | 2/13/2009 7:55 AM | Shujin | | | Xigris (Drotrecogin alfa [activated]) |
Xigris (Drotrecogin alfa [activated]) - Early Communication about an Ongoing Safety Review
Audience: Critical Care healthcare professionals
FDA is aware of a recently published study, a retrospective medical record review of 73 patients who receive Drotrecogin alfa (activated), marketed as Xigris, indicated for the reduction of mortality in adult patients with severe sepsis who have a high risk of death (Gentry et al.; Crit Care Med 2009).The study reported an increased risk of serious bleeding events and of death in patients with sepsis and baseline bleeding risk factors who received this product. Serious bleeding events occurred in 7 of 20 patients (35%) who had a bleeding risk factor vs. only 2 of 53 (3.8%) patients without any bleeding risk factors. The finding by Gentry et al. of an increased risk of death and serious bleeding events in patients treated with Xigris who also have baseline bleeding risk factors is consistent with the information in the current product label. Prescribers should refer to the product label for the specific contraindications, warnings, and, precautions and carefully weigh the increased risk of bleeding against the benefits of Xigris. FDA is working with the manufacturer to further evaluate the incidence of serious bleeding events and mortality in patients who received Xigris. FDA will communicate its conclusions and any resulting recommendations to the public when the review is completed, which may take several months.The FDA urges both healthcare professionals and patients to report side effects from the use of Xigris to the FDA's MedWatch Adverse Event Reporting program. Read the complete MedWatch 2009 Safety summary, including links to the Early Communication and the Prescribing Information, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Xigris | 2/4/2009 11:40 AM | Shujin | | | Ethex Corporation Product Recall of various prescription prenatal vitamin and iron supplement products | Nationwide recall expanded to include various prescription prenatal vitamin and iron supplement products.
Ethex Corporation Product Recall
Audience: Pharmacists, Consumers
[UPDATE 02/04/2009] ETHEX Corporation expanded the company's previous recall notices to include prescription prenatal vitamin and iron supplement products. See the 02/03/2009 Press Release for a list of products included in the recall. [Posted 01/27/2009] FDA notified pharmacists and consumers that ETHEX Corporation has expanded two previous 2008 recalls to include over 60 generic drug products recalled to wholesalers, and two generic drug products, Hydromorphone HCl and Metoprolol Succinate, recalled to retailer level. These generic products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices. Some of these products have had specific lots recalled earlier due to defects found, including oversized tablets delivering higher than labeled doses. These additional products are being removed to assure that no other defective products remain in the marketplace. Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions.
[February 03, 2009 - Press Release - Ethex]
[January 28, 2009 - Press Release - Ethex]
Previous MedWatch Alerts:
[November 2008]
[October 2008]
| 2/4/2009 11:35 AM | Shujin | | | Ethex Corporation Product Recall |
Ethex Corporation Product Recall
Audience: Pharmacists, Consumers
FDA notified pharmacists and consumers that ETHEX Corporation has expanded two previous 2008 recalls to include over 60 generic drug products recalled to wholesalers, and two generic drug products, Hydromorphone HCl and Metoprolol Succinate, recalled to retailer level. These generic products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices. Some of these products have had specific lots recalled earlier due to defects found, including oversized tablets delivering higher than labeled doses. These additional products are being removed to assure that no other defective products remain in the marketplace. Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions. Read the complete MedWatch 2009 Safety summary, including links to the firm's press release and two previous alerts, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Ethex | 1/28/2009 6:00 PM | Shujin | | | Venom HYPERDRIVE 3.0 |
FDA notified consumers not to take Venom HYPERDRIVE 3.0, a product sold as a dietary supplement but containing sibutramine, an undeclared drug product and a controlled substance with risks for abuse or addiction. When present in a dietary supplement, it may harm unsuspecting consumers because sibutramine can substantially increase blood pressure and heart rate, and may present a significant risk for people with a history of heart disease, heart failure, irregular heart beats or stroke. The product was sold via distributors and in retail stores nationwide and was packaged in red plastic bottles containing 90 capsules each with the UPC# 094922534743. Consumers who have this product should stop taking it immediately and contact their health care professional if they have experienced any adverse effects. Read the MedWatch 2009 safety summary, including a link to the FDA News Release, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Venom | 1/28/2009 6:30 AM | Shujin | | | Clopidogrel bisulfate (marketed as Plavix) | Clopidogrel bisulfate (marketed as Plavix)
Audience: Cardiovascular healthcare professionals, Pharmacists
FDA notified healthcare professionals that the makers of Plavix have agreed to work with FDA to conduct studies to obtain additional information that will allow a better understanding and characterization of the effects of genetic factors and other drugs (especially the proton pump inhibitors (PPIs)) on the effectiveness of clopidogrel. FDA is aware of published reports that clopidogrel is less effective in some patients than it is in others. Differences in effectiveness may be due to genetic differences in the way the body metabolizes clopidogrel or that using certain other drugs with clopidogrel can interfere with how the body metabolizes clopidogrel. These studies should lead to a better understanding about how to optimize the use of clopidogrel. The FDA recognizes the importance of obtaining these data promptly. The drug manufacturers have agreed to a timeline for completing the studies and FDA will review the new information expeditiously and will communicate its conclusions and any recommendations to the public at that time. It could take several months to complete the studies and analyze the results. Until further information is available FDA recommends the following:
- Healthcare providers should continue to prescribe and patients should continue to take clopidogrel as directed, because clopidogrel has demonstrated benefits in preventing blood clots that could lead to a heart attack or stroke.
- Healthcare providers should re-evaluate the need for starting or continuing treatment with a PPI, including Prilosec OTC, in patients taking clopidogrel.
- Patients taking clopidogrel should consult with their healthcare provider if they are currently taking or considering taking a PPI, including Prilosec OTC.
Read the complete MedWatch 2009 Safety summary, including a link to the Early Communication, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#plavix | 1/26/2009 3:50 PM | Shujin | | | Anesthetics - skin numbing products |
Audience: Consumers, radiological healthcare professionals, emergency room healthcare professionals, risk managers
FDA issued a public health advisory to remind patients, healthcare professionals, and caregivers about potentially serious hazards of using skin numbing products, also known as topical anesthetics, for relieving pain from mammography and other medical tests and conditions. FDA is concerned about the potential for these products to cause serious, life-threatening adverse effects, such as irregular heartbeat, seizures, breathing difficulties, coma and even death, when applied to a large area of skin or when the area of application is covered. FDA is working with healthcare professional organizations and other media that distribute healthcare information to spread the message about the potential hazards and safe use of topical anesthetics. The Advisory and the Dear Colleague letter provide recommendations to both doctors and patients on safe use of these products. Read the MedWatch 2009 safety summary, including links to the Public Health Advisory and "Dear Colleague" letter, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Anesthetics | 1/16/2009 4:40 PM | Shujin | | | Singulair (montelukast) |
Singulair (montelukast)
Audience: Pulmonologists, respiratory therapists, other healthcare professionals, patients
FDA provided updated information to its March 2008 Early Communication. FDA is continuing to review clinical trial data to assess other neuropsychiatric events, (mood and behavioral adverse events) related to drugs that act through the leukotriene pathway (montelukast, zafirlukast, zileuton). As a result, FDA has not yet reached a definitive conclusion regarding the clinical trial data on mood and behavioral adverse events associated with montelukast, zafirlukast, and zileuton. Read the complete MedWatch Safety summary, including a link to the updated early communication and the original March 2008 communication, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Singulair | 1/13/2009 4:15 PM | Shujin | | | Innohep (tinzaparin sodium injection) |
Innohep (tinzaparin sodium injection)
Audience: Hematological and Nephrological healthcare professionals, hospital risk managers
[UPDATE 12/31/2008] Celgene has issued a Dear Healthcare Professional letter describing a controlled clinical study suggesting that Innohep may increase the risk for death, compared to unfractionated heparin when used to treat elderly patients with renal insufficiency. It recommended consideration of alternatives to Innohep when treating these patients for deep vein thrombosis with or without pulmonary embolism. Read the complete MedWatch 2008 Safety summary, including a link to the Dear Healthcare Professional letter and the December 2 FDA Ongoing Safety Review, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Innohep | 12/31/2008 5:35 PM | Shujin | | | Hydromorphone HCl 2 mg Tablets |
Hydromorphone HCl 2 mg Tablets
Audience: Pharmacists, consumers, primary care healthcare professionals
ETHEX and FDA notified heathcare professionals of a nationwide recall of a single lot of Hydromorphone HCl 2 mg Tablets due to potential for oversized tablets. Hydromorphone is a drug used for pain management. If someone were to take a higher than expected dose of Hydromorphone, the risk of adverse effects known to be associated with the drug may be increased, including respiratory depression (difficulty or lack of breathing), low blood pressure, and sedation. The recalled tablets are a blue, round tablet with a script "E" on one side and a "2" on the other side. The parent company of ETHEX Corporation, KV Pharmaceutical has advised FDA that it is voluntarily suspending shipments of all FDA-approved drug products in tablet form. This action is being taken as a precautionary measure, to allow KV to address manufacturing issues that have come to management’s attention. Read the complete MedWatch 2008 Safety summary, including links to the Ethex and KV press releases and a list of KV products affected by the suspension, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Hydromorphone | 12/24/2008 1:45 PM | Shujin | | | Stryker Custom Cranial Implant Kits |
Stryker Custom Cranial Implant Kits
Audience: Maxillofacial surgeons, hospital risk managers
Stryker Leibinger USA and FDA notified healthcare professionals of a Class 1 recall of all sizes of the cranial implant kit distributed from November 5, 2007 through October 23, 2008. The company is recalling these products because sterility cannot be assured. Custom cranial implants are designed individually for each patient to correct trauma and/or defects in the lower jaw, upper jaw and face or the cranium and the face. Implanting surgeons were notified individually of the problem in a October 24, 2008 recall letter. The letter advised them of the risk for serious infections, and instructed them to follow-up with patients for infections for at least six months after surgery. The recall letter also included details for identifying and returning any remaining implant kits. Read the complete MedWatch 2008 Safety summary, including a link to the Class 1 recall notice, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Stryker | 12/24/2008 1:50 AM | Shujin | | | 25 different weight loss products |
FDA alerted consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk. The undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant ( a drug not approved for marketing in the United States), phenytoin ( an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent). The weight loss products, some of which are marked as "dietary supplements," are promoted and sold on various web sites and in some retail stores. FDA advises consumers who use the products to stop taking them and consult their healthcare professional immediately as the health risks posed by these products can be serious (for example, high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke). FDA also encourages consumers to seek guidance from healthcare professional before purchasing weight loss products. See the FDA News Release for a listing of the names of the 25 referenced products. Read the MedWatch 2008 safety summary, including links to the News Release and Questions and Answers, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Weight | 12/22/2008 6:30 AM | Shujin | | | Laryngoscope Blades |
SunMed Greenline/D MacIntosh No. 3 Laryngoscope Blades
Audience: ENT, anesthesia, and critical care healthcare professionals, hospital risk managers
Sun Med and FDA notified healthcare professionals of the Class 1 recall of Greenline/D MacIntosh No. 3 Laryngoscope Blades. This product is a part of a medical device [laryngoscope] used to view the vocal cords and other structures when opening a patient’s airway. A piece of the acrylic light tube that runs along the laryngoscope blade may break off during the procedure. This device was distributed from January 16, 2007 through April 13, 2007. The company sent a notice to their distributors requesting that the product be returned. Read the complete MedWatch 2008 Safety summary, including a link to the FDA/CDRH recall notice, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#GreenlineD | 12/19/2008 5:35 PM | Shujin | | | Oral Sodium Phosphate products (OSP) for bowel cleansing |
FDA has become aware of reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate products (OSP) for bowel cleansing prior to colonoscopy or other procedures. These products include the prescription products, Visicol and OsmoPrep, and OSPs available over-the-counter without a prescription as laxatives (e.g., Fleet Phospho-soda). In some cases when used for bowel cleansing, these serious adverse events have occurred in patients without identifiable factors that would put them at risk for developing acute kidney injury. FDA is requiring the manufacturer of Visicol and OsmoPrep, the two OSPs available by prescription only, to add a Boxed Warning to the labeling for these products. FDA is also requiring that the manufacturer develop and implement a risk evaluation and mitigation strategy (REMS), which will include a Medication Guide, to ensure that the benefits of these products outweigh the risk of acute phosphate nephropathy, and to conduct a postmarketing clinical trial to further assess the risk of acute kidney injury with use of these products. FDA recommends, in light of the risk of acute phosphate nephropathy, over-the-counter laxative OSP products should not be used for bowel cleansing. Consumers should only use OSPs for bowel cleansing pursuant to a prescription from a healthcare professional. Read the MedWatch 2008 safety summary, including a link to the FDA Drug Information Page, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#OSP | 12/11/2008 5:50 PM | Shujin | | | Gravity Compensating Accessory (GCA) (Recall) |
Integra NeuroSciences and FDA notified healthcare professionals of a recall of the Gravity Compensating Accessory (GCA), manufactured in January, 2008 through May, 2008 and distributed from February 22, 2008, through June 1, 2008. The GCA is part of a system that redirects (shunts) excess fluid from the brain to the abdomen. The GCA prevents too much fluid from being redirected from the brain while sitting or standing. The recalled devices may leak cerebrospinal fluid which may cause inflammation of brain, spinal cord, or abdominal membranes, pressure on the wound created by implantation of the device, or failure of the shunt system. Patients should contact their healthcare professional with any questions or concerns. Read the MedWatch 2008 safety summary, including a link to the recall notice, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#GCA | 12/11/2008 2:15 PM | Shujin | | | Healon D Ophthalmic Viscosurgical Device (Recall) |
Advanced Medical Optics (AMO), Inc. and FDA notified healthcare professionals of a recall of Healon D Ophthalmic Viscosurgical Device, Lot Number UD30654, 30 mg/mL fill size syringes. Some of the tested OVD syringes had endotoxin levels above the required limit. These higher levels may cause intraocular inflammation and/or Toxic Anterior Segment Syndrome in patients following surgery. Healthcare professionals should stop using and remove from their inventory all units of the affected lot and contact AMO at 1-877-266-4543. Read the MedWatch 2008 safety summary, including a link to the recall notice, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Healon | 12/11/2008 2:05 PM | Shujin | | | Sodium Chloride Injection (Recall) |
Hospira, Inc. notified healthcare professionals of a recall of one lot (lot number 65-620-FW, expiration date May 1, 2010, NDC 0409-7902-09) of 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP in 1000 mL flexible plastic containers. A small number of the containers may be incorrectly labeled with a bar code for 5% Dextrose Injection, USP (NDC 0409-7922-09). The incorrect bar code could lead to a medication error resulting in the wrong drug being delivered to a patient if a bar code system is used to confirm the medication. Potential adverse events related to an error of this type include electrolyte imbalance, cardiac dysfunction, gastrointestinal disturbances, paresthesia and mental confusion. The affected lot was shipped to U.S. customers between July 2008 and September 2008. Healthcare facilities with an existing inventory should quarantine the product immediately and call Hospira Customer Care at 1-877-946-7747 for instructions on how to return it. Read the MedWatch 2008 safety summary, including a link to the company's press release, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#20meqPotChlor | 12/10/2008 2:15 AM | Shujin | | | Tenderflow Pediatric Arterial Cannulae (Recall) |
Terumo Cardiovascular Systems notified healthcare professionals of a worldwide recall of its Tenderflow Pediatric Arterial Cannulae involving 21 lot codes (see Terumo press release for complete list). Terumo received five reports of difficulty retracting the introducer from the cannula. When the introducer cannot be retracted from the cannula, the cannula must be removed and replaced, a process that may lead to aortic damage, blood loss and/or death. Healthcare professionals are advised to not use the product unless medically necessary. In those cases, the cannula should be used without the introducer. Read the MedWatch 2008 safety summary, including a link to the firm press release, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tenderflow | 12/8/2008 2:45 PM | Shujin | | | Innohep (tinzaparin sodium injection) |
Innohep (tinzaparin sodium injection)
Audience: Hematological and Nephrological healthcare professionals, hospital risk managers
FDA has received information about the clinical study: Innohep in Renal Insufficiency Study (IRIS) that was stopped in February, 2008 by the study’s Data Safety Monitoring Committee because of an interim finding of an increase in all-cause mortality in patients who received Innohep. Information on the patients enrolled in the study, on the heparin used to manufacture Innohep, and on the heparin used in the study is still being collected and analyzed. In July 2008, the company revised the prescribing information to restrict the use of Innohep in patients 90 years of age or older. FDA is concerned that the preliminary data from the IRIS study suggest that the increased risk of mortality is not limited only to patients 90 years of age or older. Therefore, FDA has requested that the company revise the labeling for Innohep to better describe the overall study results which suggest that, when compared to unfractionated heparin, Innohep increases the risk of death for elderly patients (i.e., 70 years of age and older) with renal insufficiency. Healthcare professionals should consider the use of alternative treatments to Innohep when treating elderly patients over 70 years of age with renal insufficiency and DVT, PE, or both. This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA anticipates submission of the final IRIS study report in January, 2009 and plans to complete its review soon thereafter. FDA will communicate its conclusions and any resulting recommendations to the public at that time. FDA will consider additional regulatory actions as appropriate after thorough review of all applicable data from the manufacturer of Innohep. Read the complete MedWatch 2008 Safety summary, including a link to the FDA Communication, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Innohep | 12/2/2008 10:05 PM | Shujin | | | Starcaps Dietary Supplement Capsules |
Starcaps Dietary Supplement Capsules
Audience: Consumers, healthcare professionals
Balanced Health Products, Inc. announced a recall of STARCAPS due to the presence of an undeclared drug ingredient, Bumetanide. Bumetanide is a diuretic indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease including nephrotic syndrome. Potential risks associated with the use of Bumetanide include serious and significant fluid and electrolyte loss and an elevation in uric acid concentrations. Consumers should not take Bumetanide if they are allergic to sulfonamides. Significant drug interactions with Bumetanide, such as with digoxin and lithium, may lead to an increase risk of toxicity. Patients may also be at an increased risk of hypotension (low blood pressure), fainting (syncope) and resultant injury if they have normal blood pressure or are already taking an antihypertensive medication and take STARCAPS with undeclared Bumetanide. Consumers who have this product should immediately discontinue taking it and return the product to the manufacturer. See the company's press release for specific lot number information. Read the complete MedWatch 2008 Safety summary, including a link to the firm's press release, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Starcaps | 11/28/2008 5:45 PM | Shujin | | | Zhen De Shou Fat Loss Capsules |
Zhen De Shou Fat Loss Capsules
Audience: Consumers, healthcare professionals
Fashion Sanctuary announced a recall of Zhen De Shou Fat Loss Capsules because FDA analysis found the product to contain undeclared sibutramine, an FDA approved drug used as an appetite suppressant for weight loss. This poses a potential threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. The product was primarily distributed in the U.S and sold via the Internet and the recall affects all lot codes and use by dates. Consumers who may have purchased product from this company should immediately discontinue using the product. Read the complete MedWatch Safety summary, including a link to the firm's press release, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Zhen | 11/28/2008 5:45 PM | Shujin | | | Phenytoin therapy |
FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) from phenytoin therapy in Asian patients positive for human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including Han Chinese, Filipinos, Malaysians, South Asian Indians, and Thais. Until the FDA evaluation is completed, healthcare providers who are considering the use of phenytoin or fosphenytoin should be aware of the risks and benefits described in the current prescribing information for this drug. Healthcare providers should consider avoiding phenytoin and fosphenytoin as alternatives for carbamazepine in patients who test positive for HLA-B*1502. A summary of the data currently being analyzed by FDA, and information for patients and healthcare professionals to consider, can be found in the links provided in the MedWatch safety alert. Read the MedWatch safety summary, including links to the Information for Healthcare Professionals and FDA Drug Information pages, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Phenytoin | 11/24/2008 2:35 PM | Shujin | | | Battery Caps Used with Insulin Pumps |
Animas Corporation Battery Caps Used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump
Audience: Consumers, endocrinological healthcare professionals
Animas Corporation and FDA informed consumers and healthcare professionals of a nationwide recall of battery caps used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump. The battery caps used with the above infusion pumps were manufactured from June 1, 2008 through July 31, 2008, and were distributed from June 16, 2008 through August 1, 2008. There may be an intermittent loss of contact between the battery cap and the battery compartment in the pump which may result in the device resetting. This can cause the device to stop administering insulin, which could result in an excess level of glucose in the blood (hyperglycemia). Additionally, this failure may lead to user confusion in the amount of insulin administered, contributing to errors in future doses, which may result in lower than normal level of glucose in the blood (hypoglycemia). Healthcare professionals are advised to ensure that their patients replace the battery cap on their insulin pump. Read the complete MedWatch 2008 Safety summary, including a link to the Class 1 Recall Notice, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#batterycap | 11/22/2008 9:00 AM | Shujin | | | Bisphosphonates |
Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D)
Etidronate (Didronel)
Ibandronate (Boniva)
Pamidronate (Aredia)
Risedronate (Actonel, Actonel W/Calcium)
Tiludronate (Skelid)
Zoledronic acid (Reclast, Zometa)
Audience: Geriatricians, gynecologists, orthopedic surgeons, other healthcare professionals
FDA issued an update about the Agency's review of safety data regarding the potential increased risk of atrial fibrillation in patients treated with a bisphosphonate drug. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget’s disease of the bone, and to treat bone metastases and lower elevated levels of blood calcium in patients with cancer. FDA reviewed data on 19,687 bisphosphonate-treated patients and 18,358 placebo-treated patients who were followed for 6 months to 3 years. The occurrence of atrial fibrillation was rare within each study, with most studies containing 2 or fewer events. Across all studies, no clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation was observed. Additionally, increasing dose or duration of bisphosphonate therapy was not associated with an increase rate of atrial fibrillation. Healthcare professionals should not alter their prescribing patterns for bisphosphonates and patients should not stop taking their bisphosphonate medication. Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Update of Safety Review Follow-up to the October 1, 2007, Early Communication about the Ongoing Safety Review of Bisphosphonates, regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#bisphosphonates2 | 11/14/2008 6:25 PM | Shujin | | | Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) |
Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas)
Audience: Consumers, pediatricians, other healthcare professionals
Johnson & Johnson- Merck Consumer Pharmaceuticals Company and FDA notified consumers and healthcare professionals of a voluntary recall of Infants' Mylicon Gas Relief Dye Free Drops ( Lot No. SMF007 and SMF008) sold in 1 oz plastic bottles that were distributed after October 5, 2008, nationwide. The product was recalled because some bottles could include metal fragments that were generated during the manufacturing process. Parents who have given the product to their infant and are concerned should contact their healthcare professional. Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's recall notice regarding the above issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#mylicon | 11/14/2008 4:50 PM | Shujin | | | Propafenone HCl, Isosorbide Mononitrate, Morphine Sulfate, Dextroamphetamine Sulfate Tablets |
Propafenone HCl Tablets 150 mg, 225 mg, and 300 mg
Isosorbide Mononitrate Extended Release Tablets 30 mg and 60 mg
Morphine Sulfate Extended Release Tablets 15 mg
Morphine Sulfate Immediate Release Tablets 15 mg and 30 mg Dextroamphetamine Sulfate Tablets 10 mg
Audience: Pharmacists, other healthcare professionals, patients.
Ethex Corp and FDA notified healthcare professionals of a voluntary recall of five generic products (Propafenone HCl Tablets, Isosorbide Mononitrate Extended Release Tablets, Morphine Sulfate Extended Release Tablets, Morphine Sulfate Immediate Release Tablets, and Dextroamphetamine Sulfate Tablets). The products were recalled because they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient that could result in patients receiving as much as twice the expected dosage of these drugs, which could cause serious or life-threatening consequences. Overdoses can include arrhythmias and low blood pressure with Propafenone HCl; fainting and low blood pressure with Isosorbide Mononitrate; respiratory depression and low blood pressure with Morphine Sulfate; and rapid heart rate and high blood pressure with Dextroamphetamine Sulfate. Patients who experience any adverse reactions to these drugs should contact their healthcare professional immediately. See the manufacturer's recall notice for specific lot numbers of the products affected by this recall. Read the entire MedWatch 2008 Safety Summary, including a link to the manufacturer's recall notice regarding the above issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Ethex | 11/10/2008 2:25 PM | Shujin | | | ReliOn Insulin Syringes Recall |
ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien)
Audience: Patients with insulin-dependent diabetes; pharmacists
Covidien and FDA notified patients and healthcare professionals of a recall of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles. The mislabeled syringe may result in patients receiving an overdose of as much as 2.5 times the intended dose, with serious health consequences, low blood sugar, and even death. These syringes are sold only by Wal-Mart or Sam's Club pharmacies under the ReliOn name. The recall applies only to lot number 813900. The product was distributed from Aug. 1, 2008 until Oct. 8, 2008, and includes 471,000 individual syringes in 4,710 boxes. FDA urges patients and health care professionals to check syringe packaging carefully for products with this lot number, not to use the product, and return the product to the pharmacy for replacement. The lot number can be found on the back panel of the 100 count syringe carton, or on the white paper backing of each individual syringe “peel-pack”. Read the complete MedWatch 2008 Safety summary, including a link to the FDA press release, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#ReliOn | 11/6/2008 4:35 PM | Shujin | | | Vibrational Integrated Bio-photonic Energizer (VIBE) Recall |
Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator
Audience: Healthcare professionals
FDA notified healthcare professionals of a Class I Recall of the Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator. This device has not been approved by FDA, lacks safety and effectiveness data, and is not manufactured under current good manufacturing practices. The manufacturer has submitted no evidence to FDA to support any of their claims that the product could treat or cure such diseases as cancer, depression, infection and pain. Individuals with the device should stop using it immediately and contact the manufacturer to make arrangements to return the device. Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Recall notice regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Vibe | 10/31/2008 8:55 PM | Shujin | | | HeartMate II Left Ventricular Assist System (HM II LVAS) |
Thoratec Corporation notified healthcare professionals of a worldwide correction of the HeartMate II Left Ventricular Assist System (HM II LVAS), of all serial numbers (having Catalogue No. 1355 or 102139), distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump, and potentially result in serious injury or death. The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months, and 11.4% at 36 months. Healthcare professionals with patients supported by a HeartMate II LVAS should assess the wear and fatigue of the percutaneous lead and provide proper instruction to patients on the management and care of the lead. Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding the above issue. http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeartMate | 10/28/2008 11:10 PM | Shujin | | | Transvaginal Placement of Surgical Mesh |
Transvaginal Placement of Surgical Mesh
Audience: Hospital surgical staff, OB/GYN physicians, other healthcare professionals FDA informed healthcare professionals of serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia. FDA provided recommended actions for both physicians and patients to reduce the risks. Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Public Health Notification regarding the above issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Mesh | 10/21/2008 8:45 PM | Shujin | | | Raptiva (efalizumab) |
Raptiva (efalizumab) Audience: Dermatological healthcare professionals, patients FDA notified healthcare professionals of extensive labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections with the use of Raptiva. In addition, the prescribing information will be updated to describe a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in children. Raptiva is not approved for children under 18 years of age. Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks. Health care professionals should monitor patients treated with Raptiva for the signs and symptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay. Patients identified to begin therapy with Raptiva should have received all their age-appropriate vaccinations before starting the drug. Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva. Read the complete MedWatch 2008 Safety summary, including links to the FDA press release and the revised prescribing information, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Raptiva | 10/17/2008 6:00 PM | Shujin | | | Dextroamphetamine Sulfate 5mg tablets |
Ethex Corp and FDA notified healthcare professionals of a voluntary recall of three lots of Dextroamphetamine Sulfate 5mg tablets. The product was recalled due to the potential presence of oversized tablets that may contain as much as twice the labeled amount of the active ingredient. Taking a higher than expected dose of Dextroamphetamine Sulfate may be associated with an increased risk of adverse effects such as tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset, and drug mouth. Consumers and their caregivers should not use any Dextroamphetamine Sulfate tablets that appear to be oversized and should consult their healthcare professional with any questions. Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's recall notice at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Dextroamphetamine | 10/16/2008 11:55 AM | Shujin | | | Tiotropium (marketed as Spiriva HandiHaler) |
Tiotropium (marketed as Spiriva HandiHaler)Audience: Pulmonary care health professionals and patients
FDA informed healthcare professionals that FDA has reviewed preliminary data from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium), a large, 4-year, placebo controlled clinical trial with Spiriva HandiHaler in approximately 6000 patients with chronic obstructive pulmonary disease. The preliminary results reported by Boehringer Ingelheim to the FDA showed that there was no increased risk of stroke with tiotropium bromide compared to placebo. Two recent publications reported increased risk for mortality and/or cardiovascular events in patients who received tiotropium or inhaled anticholinergics. Both studies examined cardiovascular outcomes. FDA expects to receive the complete report for UPLIFT in November 2008. Results from this trial will also help to address some issues raised about tiotropium in the two recent publications. Due to the amount of data collected in UPLIFT, a complete review of the results could take several months, at which time FDA will update this communication with the final results of the UPLIFT analysis, as well as all the available data regarding tiotropium and stroke risk. Read the complete MedWatch 2008 Safety summary, including a link both today's update and the original March 18th Early Communication, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tiotropium | 10/7/2008 2:45 AM | Shujin | | | Recall Nebion HLX-8 Magnetic Resonance Device | |
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