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| | Afluria (CSL Ltd.) Influenza Virus Vaccine: Label Change - Risk of Fever and Febrile Seizure | Afluria (CSL Ltd.) Influenza Virus Vaccine: Label Change - Risk of Fever and Febrile Seizure
AUDIENCE: Pediatrics, Family Practice
ISSUE: FDA updated the Warnings and Precautions sections of the Prescribing Information for Afluria to inform healthcare professionals that the Afluria vaccine has been associated with an increased incidence of fever and febrile seizure among young children reported in Australia, mainly among those less than 5 years of age.
BACKGROUND: FDA announced the approved vaccines for the 2010-2011 influenza season in the United States. The brand names and manufacturers for the upcoming season’s vaccines are: Afluria, CSL Limited; Agriflu, Novartis Vaccines and Diagnostics; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; FluMist, MedImmune Vaccines Inc.; Fluvirin, Novartis Vaccines and Diagnostics Limited; and Fluzone and Fluzone High-Dose, Sanofi Pasteur Inc.
The available data suggest that the increased rates of fever and febrile seizure are only associated with the Southern Hemisphere formulation of CSL’s vaccine. The available data regarding the safety of other influenza vaccines for children used in the Southern Hemisphere do not suggest an increased rate of fever or febrile seizure. FDA is requiring CSL Limited to conduct a study of Afluria in children to obtain additional information regarding the febrile events that were seen in the Southern Hemisphere. CSL Limited will not be supplying the United States with the 0.25 milliliter single-dose, prefilled syringes, which are used in very young children. The 0.5 milliliter single-dose, prefilled syringes and 5 milliliter multi-dose vials will be distributed.
RECOMMENDATION: Vaccines for the 2010-2011 influenza season are approved by FDA for the prevention of influenza in children, adolescents, and adults, including the elderly. There are several vaccines approved by FDA available in both nasal spray and injectable (“shot”) forms. Because the influenza viruses that cause people to get sick can change, each year's vaccine may be different from the previous year. Therefore, it is important to get the influenza vaccine every year. Various investigations into the cause(s) of the febrile seizures seen with Afluria vaccine are still ongoing. FDA is collaborating with Australia’s regulatory authority, other international regulatory counterparts, and CSL to obtain additional information, stay apprised and take part in the investigations. FDA, in collaboration with CDC, will closely monitor the continued safety of all influenza vaccines. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the Vaccine Adverse Events Reporting System, a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention and the Food and Drug Administration.
Read the MedWatch safety alert, including links to FDA Q&As, News Release, Product Page, and the Package Insert, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm220764.htm | 7/30/2010 10:00 PM | Shujin | | | Miracle Mineral Solution (MMS): Product as consumed produces a potent bleach | Miracle Mineral Solution (MMS): Product as consumed produces a potent bleach
AUDIENCE: Consumers, Emergency Medicine
ISSUE: FDA warned consumers not to consume or use Miracle Mineral Solution, an oral liquid solution also known as "Miracle Mineral Supplement" or "MMS." The product, when used as directed, produces an industrial bleach that can cause serious harm to health. The product instructs consumers to mix the 28 percent sodium chlorite solution with an acid such as citrus juice. This mixture produces chlorine dioxide, a potent bleach used for stripping textiles and industrial water treatment. High oral doses of this bleach, such as those recommended in the labeling, can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration.
BACKGROUND: MMS is distributed on Internet sites and online auctions by multiple independent distributors. MMS claims to treat multiple unrelated diseases, including HIV, hepatitis, the H1N1 flu virus, common colds, acne, cancer, and other conditions. The FDA is not aware of any research that MMS is effective in treating any of these conditions. MMS also poses a significant health risk to consumers who may choose to use this product for self-treatment instead of seeking FDA-approved treatments for these conditions.
RECOMMENDATIONS: Consumers who have MMS should stop using it immediately and throw it away. The FDA advises consumers who have experienced any negative side effects from MMS to consult a health care professional as soon as possible.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product 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 MedWatch safety alert, including a link to the FDA News Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm220756.htm | 7/30/2010 9:55 PM | Shujin | | | Nutraloid Labs ejaculoid XXTREME and stimuloid II |
Nutraloid Labs ejaculoid XXTREME and stimuloid II: Undeclared Drug Ingredient
AUDIENCE: Consumer
ISSUE: FDA notified consumers that lab analysis of lots of ejaculoid XXTREME and stimuloid II found that the products, sold as dietary supplements, contain sulfoaildenafil, similar to sildenafil, which is an active ingredient of an FDA-approved drug for male erectile dysfunction, making these products unapproved drugs. This active drug ingredient is not listed on the product labels and may interact with nitrates found in 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.
BACKGROUND: The recalled products were distributed in black plastic bottles to distributors and via internet sales. The company press release contains specific lot numbers and additional recall information.
RECOMMENDATION: Customers who have any of the above 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 these products.
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 MedWatch safety alert, including links to the Press Release and product photos, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm220650.htm | 7/30/2010 6:45 PM | Shujin | | | Evamist (estradiol transdermal spray): Unintended Exposure of Children and Pets to Topical Estrogen | Evamist (estradiol transdermal spray): Drug Safety Communication - Unintended Exposure of Children and Pets to Topical Estrogen
AUDIENCE: OB/GYN, Patient
ISSUE: FDA notified healthcare professionals and patients that it is reviewing reports of adverse effects from Evamist, an estrogen hormone used to reduce hot flashes during menopause. Children unintentionally exposed to the drug through skin contact with women may experience premature puberty. Female children may experience nipple swelling and breast development. Male children may experience breast enlargement.
BACKGROUND: Evamist is a topical product, sprayed on the skin on the inside of the forearm between the elbow and the wrist. FDA is currently reviewing reported adverse events and is working with the company to identify any factors that may contribute to unintended exposure. The Agency will update the public when this review is complete. FDA and the company are also evaluating ways to minimize the risk.
RECOMMENDATION: Patients should make sure that children are not exposed to Evamist and that children do not come into contact with any skin area where the drug was applied. Women who cannot avoid contact with children should wear a garment with long sleeves to cover the application site. Additional information for Healthcare Professionals, Information for Patients, and a Data Summary are provided in the Drug Safety Communication at the link below. 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 MedWatch Safety Alert, including links to the Drug Safety Communication, FDA Consumer Update, FDA News Release, and Prescribing Information, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm220548.htm | 7/29/2010 2:55 PM | Shujin | | | Cubicin (daptomycin): Risk of Eosinophilic Pneumonia | Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia
AUDIENCE: Infectious Disease, Pulmonology
ISSUE: FDA notified healthcare professionals and patients about the potential for developing eosinophilic pneumonia during treatment with Cubicin (daptomycin), an intravenous antibacterial drug indicated for use in treatment of serious skin infections and bloodstream infections. Eosinophilic pneumonia is a rare but serious condition where a type of white blood cell (eosinophil) fills the lungs. Symptoms of eosinophilic pneumonia include fever, cough, shortness of breath, and difficulty breathing. Eosinophilic pneumonia may lead to progressive respiratory failure and is potentially fatal if not quickly recognized and appropriately managed.
BACKGROUND: FDA has reviewed published case reports of Cubicin-associated eosinophilic pneumonia and conducted a review of post-marketing adverse event reports from the FDA's Adverse Event Reporting System. FDA's review identified 7 cases of eosinophilic pneumonia between 2004 and 2010 that were most likely associated with Cubicin. Based on these reviews, FDA determined that eosinophilic pneumonia can be associated with Cubicin use and requested that the manufacturer of Cubicin include this information in the Warnings and Precautions and Adverse Reactions, Post-Marketing Experience sections of the drug label.
RECOMMENDATION: Healthcare professionals should closely monitor patients being treated with Cubicin for eosinophilic pneumonia. Patients receiving Cubicin should immediately contact their healthcare professional if they develop a new or worsening fever, cough, shortness of breath, or difficulty breathing.
Additional information for Healthcare Professionals, Information for Patients, a Data Summary, and References are provided in the Drug Safety Communication.
Read the MedWatch safety alert, including links to the FDA Drug Safety Communication and Prescribing Information (drug label), at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm220499.htm | 7/29/2010 12:50 PM | Shujin | | | Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin | Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays
Sets and Trays contain Covidien 6PERC or 8PERC Shiley Tracheostomy Tube [Posted 07/22/2010]
Audience: Hospital Risk Manager, Anesthesiology
Issue: FDA notified healthcare professionals that Cook initiated a voluntary recall of certain lots of Ciaglia Blue Rhino/Blue Dolphin Percutaneous Tracheostomy Introducer
Sets/Trays that contain Covidien 6PERC or 8PERC Shiley Tracheostomy Tube due to the product’s cuff not holding air. The voluntary recall only affects lot numbers noted in the press release at link below.
Background: The defect is a result of leaks in the pilot balloon inflation assembly. If a cuff does not hold air, ventilation will be adversely affected since the ability to generate positive pressure in the airway could be compromised by lack of cuff seal. This could result in a sudden decrease in the amount of oxygen in the blood or a sudden increase in the amount of carbon dioxide in the blood, especially if the patient requires assisted mechanical ventilation and could result in serious injury, including death.
Recommendation: Cook has mailed a detailed Customer Notification letter to each customer who has received an affected lot number of these devices. Customers should review product in inventory and current use to identify product from the affected lot codes. Healthcare professionals may report adverse events or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online by regular mail or fax.
• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: Use postage-paid FDA form 3500 available at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
• Mail to address on pre-addressed form or fax to 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/ucm220022.htm | 7/22/2010 10:55 PM | Shujin | | | Joyful Slim Herb Supplement : Recall | Joyful Slim Herb Supplement : Recall-Undeclared Drug Ingredient
Audience: Consumers
Issue: FDA lab analysis of this herb supplement was found to contain the undeclared drug, desmethyl sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss. 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.
Background: This product is marketed as a Natural Herb for Weight Loss, is packaged in plastic bottles containing 30 capsules per bottle and bears UPC 8 97966 00200 7. The affected lot/code being recalled is 101408. The product was sold to distributors and retail stores nationwide and via internet sales. The company has discontinued distribution of Joyful Slim.
Recommendations: Consumers should not consume the product and should return it immediately to the place of purchase for a full refund. Any adverse reactions experienced with the use of this product may 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 by 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/ucm219983.htm | 7/22/2010 10:50 PM | Shujin | | | CONSTELLATION Vision System: Recall | CONSTELLATION Vision System: Recall
AUDIENCE: Eye care, Surgery, Risk Manager
ISSUE: Alcon initiated the recall after it identified both software and hardware problems which have been associated with unexpected system loss of power (shutdowns), unintended system error messages, unresponsive touchscreens, and system setting and infusion performance problems. These events may cause eye injuries, including blindness.
BACKGROUND: The Alcon CONSTELLATION Vision System is an ophthalmic microsurgical system used by eye surgeons to perform various types of eye surgery. All model and catalog numbers are affected by this recall and are listed in the FDA Recall Notice. These devices were manufactured and distributed from September 1, 2008 through April 30, 2010.
RECOMMENDATION: Report adverse events or side effects related to the use of this product 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 Recall Notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm219665.htm | 7/20/2010 4:00 PM | Shujin | | | Vialipro Dietary Supplement: Recall | Vialipro Dietary Supplement: Recall- Undeclared Drug Ingredient
AUDIENCE: Consumers
ISSUE: Good Health, Inc. is conducting a voluntary recall after an FDA lab analyses found that the product tested from certain batches of Vialipro contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making this product an unapproved drug. 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.
BACKGROUND: This product is currently being sold as a dietary supplement throughout the U.S. The affected lot numbers being recalled can be found in the company's Press Release.
RECOMMENDATION: Consumers who have purchased Vialipro should discontinue its use and return it to Good Health, Inc. Report adverse events or side effects related to the use of this product 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 company Press Release , at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm219580.htm | 7/20/2010 3:20 PM | Shujin | | | Slim-30 Herb Supplement: Undeclared Drug Ingredient |
Slim-30 Herb Supplement: Undeclared Drug Ingredient
AUDIENCE: Consumers
ISSUE: FDA lab analysis of Slim-30 Herb Supplement distributed by the company was found to contain undeclared N-Desmethyl Sibutramine and traces of Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved this product, therefore the safety and effectiveness of the product is unknown. This product poses 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.
BACKGROUND: Slim-30 Herb Supplement is marketed as a Natural Herb for Weight Loss. Slim-30 Herb Supplement is packaged in plastic bottles containing 30 capsules per bottle and bears UPC 8 31457 005009 2. The affected lot/code being recalled is 032009. The product was sold to distributors and retail stores nationwide and China and via internet sales. No illnesses or injuries have been reported to the company to date in connection with this product.
RECOMMENDATION: Consumers should not consume the Slim-30 Herb Supplement and should return it immediately to the place of purchase for a full refund. 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 MedWatch safety alert, including a link to the company Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm219463.htm | 7/19/2010 2:25 PM | Shujin | | | Angiotensin Receptor Blockers (ARBs): Ongoing Safety Review for Cancer Risk | Angiotensin Receptor Blockers (ARBs): Ongoing Safety Review for Cancer Risk
AUDIENCE: Cardiology, Oncology, Family Practice
ISSUE: A recently published study - a meta-analysis combining cancer-related findings from several clinical trials - suggested use of ARBs may be associated with a small increased risk of cancer.
BACKGROUND: ARBs are used in patients with high blood pressure and other conditions. Brand names include Atacand, Avapro, Benicar, Cozaar, Diovan, Micardis, and Teveten.
The meta-analysis included data from over 1,000 patients in several long-term, randomized, controlled clinical trials evaluating ARBs for which adverse events related to cancer were captured during the study. The mean duration of follow-up ranged from 1.7 to 4.8 years. The study reported the frequencies of new cancer occurrence to be 7.2% for patients receiving ARBs compared to 6.0% for those not receiving ARBs (risk ratio = 1.08, 95% Confidence Interval: 1.01-1.15). No statistically significant difference in cancer deaths was noted.
RECOMMENDATION: FDA has not concluded that ARBs increase the risk of cancer. The Agency is reviewing information related to this safety concern and will update the public when additional information is available. FDA believes the benefits of ARBs continue to outweigh their potential risks.
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 MedWatch safety alert page, including a link to the Drug Safety Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm219185.htm | 7/15/2010 3:30 PM | Shujin | | | Coumadin 1 mg Tablet Blister Packs: Recall | Coumadin 1 mg Tablet Blister Packs: Recall
AUDIENCE: Hematology, Cardiology, Risk Manager
ISSUE: Bristol-Myers Squibb determined that some of the tablets, over time, may not meet specification for isopropanol. Isopropanol is used to maintain the active ingredient, Coumadin, in the crystalline state, and could affect the therapeutic levels of the active ingredient. A decrease of active ingredient may increase the risk of clots which could lead to heart attack or stroke, and if there is too much active ingredient, there is an increased risk of bleeding. The following lot numbers are included in this recall: Physician Sample Blister Packs: Lot# 9A48931A, 9A48931B, 9A48931C, expiration January 2012; HUD Blister Pack: Lot# 8F34006B, 8K44272A, 8K46168A, 9F44437A and 9K58012B with expiry dates between June 2011 and November 2012.
BACKGROUND: The recall only involves Coumadin 1 mg tablet blister-packs distributed in the U.S. This recall does not involve Coumadin 1 mg supplied in bottles or any other strengths and dosage forms of the product. Patients who may have product from the subject lots should contact their physicians to ensure that their anticoagulation therapy is not interrupted.
RECOMMENDATION: See the company Press Release for additional contact information. 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 MedWatch safety alert, including a link to the company press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm218955.htm | 7/14/2010 9:45 AM | Shujin | | | Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury | Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury
AUDIENCE: Rheumatology, Family Practice
ISSUE: FDA is adding information on severe liver injury to the Boxed Warning of Arava (leflunomide) a drug used to treat rheumatoid arthritis - to highlight the risk of severe liver injury in patients using this drug and how this risk may be reduced. FDA previously required a Boxed Warning stating that leflunomide was contraindicated in pregnant women, or women of childbearing potential who were not using reliable contraception.
BACKGROUND: The decision to add information on severe liver injury to the Boxed Warning was based on FDA’s review of adverse event reports which identified 49 cases of severe liver injury, including 14 cases of fatal liver failure, between August 2002 and May 2009. In this review, the greatest risk for liver injury was seen in patients taking other drugs known to cause liver injury, and patients with pre-existing liver disease.
RECOMMENDATIONS: The information on severe liver injury being added to the Boxed Warning states:
• Patients with pre-existing liver disease should not receive leflunomide.
• Patients with elevated liver enzymes (ALT greater than two times the upper limit of normal) should not receive leflunomide.
• Caution should be used in patients who are taking other drugs that can cause liver injury.
• Liver enzymes should be monitored at least monthly for three months after starting leflunomide and at least quarterly thereafter.
• If the ALT rises to greater than two times the upper limit of normal while the patient is on leflunomide – leflunomide should be stopped, cholestryamine washout begun to speed the removal of leflunomide from the body and follow-up liver function tests conducted at least weekly until the ALT value is within normal range.
Read the MedWatch safety alert, including a link to the Drug Safety Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm218912.htm | 7/13/2010 5:05 PM | Shujin | | | Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism |
Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism
AUDIENCE: Surgery, Operating Room Nursing
ISSUE: FDA has received reports of air or gas embolism occurring during or immediately after application of hemostatic drug or biological products using air- or gas-pressurized sprayers. These adverse events appear to be related to use of spray devices inconsistent with the approved product labeling and instructions for use. In some reports the device was used at higher than recommended pressure or at a distance too close to the surface of the bleeding site. Although rare, the reports describe air embolisms that are life threatening and include one fatality.
BACKGROUND: The manufacturers of all fibrin sealants licensed in the U.S. have updated the Warning and Precautions sections of the labels of EVICEL, Tisseel and ARTISS to emphasize the risk of air embolism and the need to use the recommended ranges of pressure and distance. The labeling of the spray devices and non-fibrin hemostatic drug or biological products also includes information on recommended pressures and distances.
RECOMMENDATIONS: Clinicians using air- or gas-pressurized spray devices for application of hemostatic drug or biological products should:
• Use the applicator, spray set, and pressure control device or regulator as recommended in the labeling or Information For Use of the hemostatic agent.
• Use an air or gas pressure setting within the range recommended by the manufacturer of the sprayer.
• Ensure that distance between the spray head and the tissue surface is not less than the minimum recommended by the manufacturer of the sprayer.
• Monitor blood pressure, pulse, oxygen saturation and end tidal CO2 for signs of an air or gas embolism.
• Make sure the regulators are maintained properly and checked for safe performance regularly.
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 MedWatch safety alert, including links to the FDA Safety Notification and product labels, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm218530.htm | 7/9/2010 2:35 PM | Shujin | | | Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System: Class I Recall | Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System: Class I Recall
Audience: Risk Manager, Laboratory, Infectious Disease
ISSUE: The firm received increasing numbers of complaints for false negative MRSA results when compared to MRSA positive results received from culture methods. All Cepheid MRSA/SA Blood Culture Assay products have a potential of generating infrequent rates of false negative MRSA results, which could result in incorrect treatment or delay of care for patients with MRSA infection.
BACKGROUND: This test is used to detect methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) DNA directly from patient positive blood culture determined to be Gram Positive Cocci in Clusters (GPCC) or Gram Positive Cocci in singles (GPC) by Gram stain.
RECOMMENDATION: On July 1, 2010, the company issued a press release and sent its customers a revised Corrective Action Notice letter instructing them not to report the MRSA negative result when a MRSA negative/SA positive result is generated on the Cepheid MRSA/SA Blood Culture Assay. Instead, customers were instructed to conduct further antimicrobial susceptibility testing to determine the MRSA result. The MRSA positive/SA positive results generated on the Cepheid MRSA/SA Blood Culture Assay can still be reported. Read the MedWatch safety alert, including a link to the FDA Class I Recall Notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm218038.htm | 7/2/2010 9:50 PM | Shujin | | | LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors Recall | LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.: Class I Recall Due To Power Supply Failure
Audience: Emergency Medicine, Cardiology, Risk Manager
ISSUE: A failure on the power supply assembly can result in either "No DC power" or "No DC or AC power". A failure of DC (battery) power can result in the inability to deliver defibrillation therapy if the device will not turn on using DC (battery) power and no AC (line) power is available.
BACKGROUND: The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitor is designed for use by trained medical personnel in hospitals and clinic settings to monitor patient heart rhythms and to treat patients experiencing cardiac arrest. Approximately 42,943 devices were distributed worldwide between September 16, 2002 and September 27, 2007. These devices were manufactured from July 31, 2002 to September 19, 2007.
RECOMMENDATION: All affected power supplies will be updated. Customers are advised to keep the defibrillators in service and follow recommended daily Operator Checklist steps while service updates are scheduled. See Recall Notice for contact information.
Read the MedWatch safety alert, including a link to the FDA Class I Recall Notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm217980.htm | 7/2/2010 7:25 PM | Shujin | | | Kellog's popular cereals recalled | Kellog recalls millions of their cereals due to reported odd oders and flavor. Affected cereals are: Apple Jacks,
Froot Loops, Honey Smacks, and Corn Pops
| 6/28/2010 12:15 AM | Shujin | | | Mylotarg (gemtuzumab ozogamicin): Market Withdrawal | Mylotarg (gemtuzumab ozogamicin): Market Withdrawal
Audience: Oncology, Hematology
ISSUE: FDA notified healthcare professionals that results from a recent clinical trial raised new concerns about the product’s safety, and the drug failed to demonstrate clinical benefit to patients enrolled in trials.
BACKGROUND: Mylotarg (gemtuzumab ozogamicin), indicated for treatment of acute myeloid leukemia (AML), a bone marrow cancer, was approved in May 2000 under the FDA’s accelerated approval program. A confirmatory, post approval clinical trial was begun by Wyeth (now Pfizer) in 2004. The trial was designed to determine whether adding Mylotarg to standard chemotherapy demonstrated an improvement in clinical benefit (survival time) to AML patients. The trial was stopped early when no improvement in clinical benefit was observed, and after a greater number of deaths occurred in the group of patients who received Mylotarg compared with those receiving chemotherapy alone.
RECOMMENDATION: Mylotarg will not be commercially available to new patients. Patients who are currently receiving the drug may complete their therapy following consultation with their healthcare professional. Healthcare professionals should inform all patients receiving Mylotarg of the product’s potential safety risks. Any future use of Mylotarg in the United States will require submission of an investigational new drug application to the FDA. Read the complete MedWatch safety alert, including a link to the FDA News Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm216458.htm | 6/21/2010 4:25 PM | Shujin | | | Magic Power Coffee: Undeclared Drug Ingredient | Magic Power Coffee: Undeclared Drug Ingredient
Audience: Consumers, Family Practice
ISSUE: Magic Power Coffee, an instant coffee product marketed as a dietary supplement for sexual enhancement, contains the drug ingredient hydroxythiohomosildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. Hydroxythiohomosildenafil, like sildenafil, may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. FDA is warning consumers not to use this product.
BACKGROUND: The product is distributed on Internet sites and online auctions by multiple independent distributors participating in an online multi-level marketing scheme. It is sold in a 2-serving box and a 12-serving carton containing six 2-serving boxes.
RECOMMENDATION: Consumers who have Magic Power Coffee should stop using it immediately. The FDA advises consumers who have experienced any negative side effects from sexual enhancement products to consult a health care professional and to safely discard the product.
Read the complete MedWatch safety alert, including links to the FDA News Release and Consumer Update on the Hidden Risks of Erectile Dysfunction "Treatments" Sold Online, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm216355.htm | 6/21/2010 10:55 AM | Shujin | | | Dangerous: Tamiflu: Counterfeit Product Sold on Internet | Tamiflu: Counterfeit Product Sold on Internet
Fraudulent product is dangerous to patients allergic to penicillin
Audience: Consumers, Pharmacists
Issue: FDA notified consumers and healthcare professionals about a potentially harmful product represented as “Generic Tamiflu” sold over the Internet. FDA tests revealed that the fraudulent product does not contain Tamiflu’s active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin. Patients who are allergic to penicillin products are at risk of experiencing similar reactions from cloxacillin. This includes a sudden, potentially life-threatening reaction called anaphylaxis, with symptoms that include difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness, or a rapid or weak pulse.
Background: The FDA bought the fraudulent “Generic Tamiflu” without a prescription from a website claiming to be an online drugstore that is no longer operational. The fraudulent version is likely to be found for sale on other websites, however. Legitimate internet pharmacies are licensed by the appropriate U.S. Board of Pharmacy and follow the applicable laws and regulations. Consumers can also be confident that the National Association of Boards of Pharmacy Verified Internet Pharmacy Sites Seal, also known as VIPPS Seal, gives a seal of approval to pharmacy sites that apply and meet state licensure requirements. Legitimate pharmacies that carry the VIPPS seal are listed at www.vipps.info
Recommendation: The FDA advises anyone possessing or encountering any of these fraudulent Tamiflu drugs not to use them and to contact the FDA's Office of Criminal Investigations by visiting the OCI website (http://www.fda.gov/OCI).
Consumers 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 FDA news release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm216183.htm | 6/17/2010 8:00 PM | Shujin | | | Vitamin D Supplement Products | Vitamin D Supplement Products: Medication Use Error
Audience: Pediatrics, Family Practice, Consumer
ISSUE: Some liquid Vitamin D supplement products are sold with droppers that could allow parents to accidentally give harmful amounts of Vitamin D to their infant. Excessive amounts of Vitamin D can be harmful to infants, and may be characterized by nausea and vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, and fatigue, as well as more serious consequences like kidney damage.
BACKGROUND: The American Academy of Pediatrics has recommended a dose of 400 International Units (IU) of Vitamin D Supplement per day to breast-fed and partially breast-fed infants (AAP Pediatric Nutrition Handbook, 6th edition, p.466).
RECOMMENDATION: The easiest way to insure that an infant will not get more than the recommended dose is to use a product supplied with a dropper that will give no more than 400 IU per dose. If a caregiver cannot clearly determine the dose of Vitamin D that should be given to an infant or has any other questions, FDA recommends consulting with a healthcare provider before giving any of these products to an infant.
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 safety alert, including links to the FDA Note to Correspondents and the FDA Consumer Update, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm215523.htm | 6/15/2010 2:45 PM | Shujin | | | Benicar (olmesartan): Ongoing Safety Review | Benicar (olmesartan): Ongoing Safety Review
Audience: Cardiology, Internal Medicine
[Posted 06/11/2010]
ISSUE: FDA is evaluating data from two clinical trials in which patients with type 2 diabetes taking the blood pressure medication, Benicar (olmesartan), an angiotensin II receptor blocker, had a higher rate of death from a cardiovascular cause compared to patients taking a placebo. FDA's review is ongoing and the Agency has not concluded that Benicar increases the risk of death. FDA currently believes that the benefits of Benicar in patients with high blood pressure continue to outweigh its potential risks.
BACKGROUND: The Agency plans to review the primary data from the two studies of concern, ROADMAP and ORIENT, and is considering additional ways to assess the cardiovascular effects of Benicar. ROADMAP and ORIENT are both long-term clinical trials. In both trials, patients with type 2 diabetes were given either Benicar or placebo to determine if treatment with Benicar would slow the progression of kidney disease. An unexpected finding observed in both trials was a greater number of deaths from a cardiovascular cause (heart attack, sudden death, or stroke) in the Benicar-treated patients compared to placebo.
RECOMMENDATION: Follow the recommendations in the drug label when prescribing Benicar. Additional Information for Patients, for Healthcare Professionals and a Data Summary are provided in the Drug Safety Communication below. Additional information about ROADMAP and ORIENT can be found at clinicaltrials.gov.
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 safety summary, including a link to the FDA Drug Safety Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm215249.htm | 6/11/2010 11:45 AM | Shujin | | | Hospira Brand Liposyn and Propofol: Recall | Hospira Brand Liposyn and Propofol: Recall
Propofol Injectable Emulsion 1%, Liposyn (Intravenous Fat Emulsion) products including Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, and Liposyn III 30%
Audience: Anesthesiology, Risk Manager
ISSUE: Hospira notified healthcare professionals of a voluntary recall of several injectable products because some of the containers may contain particulate matter, primarily made up of sub-visible inert stainless steel particles. 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 (SIRS). Restriction in blood supply to tissues could lead to stroke, respiratory failure, kidney failure, liver failure, heart attack and/or death.
BACKGROUND: Hospira initially announced a recall of propofol and Liposyn to its customers on March 31, 2010. The expanded recall affects additional lots of propofol and Liposyn distributed during a wider timeframe to capture all product that might currently be in customer inventories. Lot numbers and expiration dates can be found in the firm's press release below. The affected lots of Liposyn were distributed between December 2008 and April 2010.
RECOMMENDATION: Anyone with an existing inventory should stop use and distribution and quarantine the product immediately and call Stericycle at 1-877-884-7835 to arrange for the return of these products. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products.
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 safety alert, including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm215033.htm | 6/10/2010 8:55 PM | Shujin | | | Defibtech DBP-2800 Battery Packs used in Lifeline AED and ReviveR AED: Recall |
Defibtech DBP-2800 Battery Packs used in Lifeline AED and ReviveR AED: Recall
Audience: Emergency Medicine
ISSUE: Defibtech, LLC, notified customers of a recall of 5,418 DBP-2800 Battery Packs used in the Lifeline AED and ReviveR AED (semi-automatic external defibrillators). When the AED is used with an affected battery pack, the AED may falsely detect an error condition during charging for a shock, then cancel charge and not provide therapy.
BACKGROUND: This recall affects all DBP-2800 Battery Packs shipped prior to June 4, 2007. The DBP-2800 battery packs affected by this recall have been distributed globally to fire departments, EMS, health clubs, schools, and other organizations.
RECOMMENDATION: The company has identified recommendations for the end customer to follow until the battery pack has been corrected, which allows the battery pack to remain in service. A copy of these recommendations is being mailed to all affected customers, and is available on the web at http://www.defibtech.com/batteryFA. Read the complete MedWatch Safety Summary including a link to the firm press release at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm214916.htm | 6/9/2010 12:35 PM | Shujin | | | GammaGard Liquid, Immune Globulin Intravenous (Human) |
GammaGard Liquid, Immune Globulin Intravenous (Human)
Audience: Allergy and Immunology, Pediatrics
ISSUE: Baxter BioScience and FDA notified healthcare professionals of a market withdrawal being conducted as a precautionary measure due to an increased number of adverse event reports of allergic reactions associated with two lots of the product.
BACKGROUND: GammaGard Liquid is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity.
RECOMMENDATION: Customers are asked to contact Baxter BioScience for Urgent Market Withdrawal instructions. See the Market Withdrawal Notice for information on affected lots.
Read the complete MedWatch 2010 Safety summary, including a link to the Market Withdrawal Notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm214497.htm | 6/5/2010 7:45 PM | Shujin | | | Intravenous Medications Manufactured by Claris: Recall | Intravenous Medications Manufactured by Claris: Recall due to contamination of products
Metronidazole, Ciprofloxacin and Ondansetron sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels.
Audience: Pharmacists, Hospital Risk Managers
FDA notified healthcare professionals not to use the intravenous medications, metronidazole, ciprofloxacin and ondansetron manufactured by Claris Lifesciences due to contamination. These products were all manufactured on the same manufacturing line and sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels. The FDA received reports of floating matter in intravenous bags of metronidazole and ondansetron. Foreign matter should not be present in a sterile injectable product. Healthcare professionals should not use these products and should immediately remove them from their pharmacy inventories. Claris is initiating a recall of all lots of these products. FDA is further investigating the situation and will notify the public when new information becomes available. Please review the linked Public Health Alert for a list of the affected and recalled products. Read the complete MedWatch 2010 Safety summary, including a link to the Public Health alert, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm214034.htm | 5/30/2010 10:00 AM | Shujin | | | PediaCare Children's Products [Blacksmith Brand]: Recall | PediaCare Children's Products [Blacksmith Brand]: Recall of four products
• PediaCare Multi-Symptom Cold
• PediaCare Long Acting Cough
• PediaCare Decongestant
• PediaCare Allergy and Cold
Audience: Consumers,, Pediatrics healthcare professionals
Blacksmith Brands and FDA notified healthcare professionals and patients about a nationwide recall of all lots of four PediaCare children's products. These products are sold exclusively in the United States and were manufactured by McNeil Consumer Healthcare at McNeil's Fort Washington, PA plant. The four PediaCare items involved in the recall are:
• PediaCare Multi-Symptom Cold 4oz. UPC # 3 0045-0556-05 9
• PediaCare Long Acting Cough 4oz. UPC# 3 0045-0465-04 7
• PediaCare Decongestant 4oz. UPC# 3 0045-0554-04 8
• PediaCare Allergy and Cold 4oz. UPC# 3 0045-0552-04 4
Blacksmith Brands initiated the recall as a precautionary step because the products were manufactued at a McNeil plant in which a recent FDA inspection found serious problems in meeting FDA's current good manufacturing practice requirements. The company advises consumers who have purchased these recalled products to discontinue use. Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm214036.htm | 5/30/2010 9:55 AM | Shujin | | | Hylenex recombinant (hyaluronidase human injection): Recall | Hylenex recombinant (hyaluronidase human injection): Recall - Voluntary recall
Audience: Risk Manager, Emergency Medicine
[Posted 05/26/2010] Baxter International Inc. announced a voluntary recall of all manufactured lots of Hylenex recombinant (hyaluronidase human injection) has been initiated as a precautionary measure due to instances of particulate matter observed in a limited number of vials during routine stability testing. To date, no medical events or customer complaints associated with this issue have been reported. As part of this stability testing for Hylenex recombinant, a limited number of vials were observed to contain small, flake-like particles, identified as glass. The company estimates that there are approximately 3,500 vials in the marketplace. Baxter is working with the product's NDA-holder, Halozyme Therapeutics, to investigate the root cause of the issue and appropriately address the situation. Read the complete MedWatch safety summary, including the link to the Firm Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213532.htm | 5/26/2010 6:05 PM | Shujin | | | Orlistat (marketed as Alli and Xenical) | Orlistat (marketed as Alli and Xenical): Labeling Change
Audience: Family Practice healthcare professionals, patients/consumers
FDA notified healthcare professionals and patients that it has approved a revised label for Xenical to include new safety information about cases of severe liver injury that have been reported rarely with the use of this medication. The agency is also adding a new warning about rare reports of severe liver injury to the OTC Drug Facts label for Alli. Xenical and Alli are medications used for weight-loss that contain different strengths of the same active ingredient, orlistat. Xenical (orlistat 120 mg) is available by prescription and Alli (orlistat 60 mg) is sold over-the-counter without a prescription. This new safety information, originally announced in August 2009, is based on FDA's completed review of orlistat. Healthcare professionals should weigh the benefits of weight-loss with the potential risks associated with Xenical and Alli before prescribing or recommending these medications to their patients; patients should stop use of orlistat and contact their healthcare professional if they develop the signs and symptoms of liver injury, including itching, yellow eyes or skin, dark urine, light-colored stools, or loss of appetite. Read the complete MedWatch safety summary, including links to the FDA Drug Safety Communication and Questions and Answers pages, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213448.htm | 5/26/2010 6:05 PM | Shujin | | | Metronidazole injection | Metronidazole injection 500 mg / 100 ml: Voluntary recall due to non-sterility
Audience: Infectious Disease, Pharmacy
Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of all lots of metronidazole injection, USP 500mg / 100mL manufactured by Claris Lifesciences and distributed by Sagent due to the discovery of non-sterility in two lots of metronidazole injection. Non-sterility of an antimicrobial administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised. Sagent is not aware of any adverse patient events resulting from this product and is continuing its diligent investigation of the situation. The lot numbers being recalled are: A090742, A090743, A090744, A090745, A090746, A090769, A090770, A090771, A090772, A090773, A090774, A090775, A090776, A090968, A091014, A000013, A000016 and A000019, which were distributed to hospitals, wholesalers and distributors nationwide from February through May 2010. Metronidazole injection, USP is an intravenous antimicrobial product used to treat infections and is supplied in a single dose plastic container. Read the complete MedWatch 2010 Safety alert including a link to the firm press release at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm212311.htm | 5/18/2010 12:10 AM | Shujin | | | Rotarix Vaccine | Rotarix Vaccine: Update to Clinicians and Public Health Professionals
Audience: Pediatric and family practice healthcare professionals, public health professionals
[UPDATED 05/16/2010] FDA has determined it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq. Based on a careful evaluation of laboratory results from the manufacturers and its own laboratories, a thorough review of the scientific literature, and input from scientific and public health experts, the agency is revising its recommendation to temporarily suspend use of the Rotarix vaccine. FDA has also determined that RotaTeq vaccine should remain in use. In its decision, FDA considered that both vaccines have strong safety records, including clinical trials involving tens of thousands of patients as well as clinical experience with millions of recipients. FDA has no evidence that either porcine circovirus (PCV1 or PCV2) poses a safety risk in humans, and notes that neither is known to cause infection or illness in humans. The benefits of the vaccines are substantial, and include prevention of hospitalization for severe rotavirus disease in the United States and of death in other parts of the world. he benefits outweigh the risk, which is theoretical. FDA and the manufacturers will continue to investigate the findings of PCV in rotavirus vaccines and will evaluate information from ongoing testing by FDA and the manufacturers. Read the complete MedWatch 2010 Safety summary, including the original March 22 notice and links to the updates for Healthcare Professionals and for Parents/Caregivers, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm205640.htm | 5/16/2010 6:00 PM | Shujin | | | GE Healthcare Aisys and Avance Anesthesia Systems: Recall | GE Healthcare Aisys and Avance Anesthesia Systems: Recall
Audience: Anesthesiology healthcare professionals
GE and FDA notified healthcare professionals of a Class I Recall of specific lots of the Aisys and Avance Anesthesia Systems. The control board wiring harnesses have a defect which can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring. Healthcare professionals are encouraged to report adverse events 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 Recall Notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm211918.htm | 5/13/2010 3:30 PM | Shujin | | | Promacta (eltrombopag) | Promacta (eltrombopag): Portal Venous System Thromboses in Study of Patients With Chronic Liver Disease
Audience: Hematology healthcare professionals
GlaxoSmithKline and FDA notified healthcare professionals of a new safety finding in patients with thrombocytopenia due to chronic liver disease treated with eltrombopag, a thrombopoietin receptor agonist approved for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura. The ELEVATE study, a randomized, double-blind, placebo-controlled, multinational study was terminated following the identification of an imbalance of thrombosis of the portal venous system in the patients treated with eltrombopag versus matching placebo. Six patients (4%) in the eltrombopag group and one (1%) in the placebo group experienced a thrombotic event of the portal venous system. Five of the six patients treated with eltrombopag experienced the portal venous thrombosis at platelet counts above 200,000/μL. GSK has communicated this safety finding to clinical trial investigators and regulatory agencies. GSK is working with regulatory agencies to include this safety information in the label. Action required by Health Care Professionals:
• Health Care Professionals are reminded that Promacta is indicated for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) and is not indicated for the treatment of thrombocytopenia in patients with chronic liver disease.
• Treatment with Promacta should be aimed at increasing the platelet count to a level that reduces the risk of bleeding; Promacta should not be used in an attempt to normalize the platelet count.
• Use caution when administering Promacta to patients with known risk factors for thromboembolism.
• Exercise caution when administering Promacta to patients with hepatic disease. Use a lower starting dose (25mg once daily) of Promacta in patients with moderate to severe hepatic disease and monitor closely.
Read the complete MedWatch 2010 Safety summary, including a link to the Dear Healthcare Professional letter, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm211796.htm | 5/12/2010 8:30 PM | Shujin | | | Benadryl Extra Strength Itch Stopping Gel | Benadryl Extra Strength Itch Stopping Gel: Packaging Changes to Reduce Use Errors
Audience: Consumers, Pharmacists
Johnson & Johnson and FDA notified consumers and healthcare professionals of changes to the graphics and information displayed on the front of the product container to reduce the risk of serious side effects from swallowing the topical Benadryl Extra Strength Itch Stopping Gel intended “For Skin Use Only". FDA received reports of consumers ingesting the gel rather than using it topically. Swallowing the gel can result in people receiving dangerously large amounts of the active ingredient diphenhydramine. Between 2001 and 2009, 121 cases of ingestion of Benadryl Extra Strength Itch Relief Gel were reported to the manufacturer. Of these cases, 7 were considered serious because patients required treatment in the emergency room, hospitalization, or admission to the intensive care unit. Others reported adverse events included hallucinations, unconsciousness, sleepiness, difficulty walking, dizziness and inability to speak. Read the complete MedWatch 2010 Safety summary, including a link to the Drug Safety communication and consumer update, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm211792.htm | 5/12/2010 8:25 PM | Shujin | | | Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier: Recall | Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570): Recall
Audience: Hospital Risk Managers
FDA and Teleflex Medical notified healthcare professionals of a worldwide voluntary recall affecting certain lot numbers of the Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (HCH) (catalog number 1570), a passive humidifier indicated for use to effectively warm and humidify inspired gas during mechanical ventilation. The 22cm connector on the flex tube may not fit securely within the endotracheal tube (ET) connector. This may result in the product becoming disconnected from the patient ET tube. Device failure is recognizable by the user as an alarm from the ventilator, oxygen sensor or other compatible device to which the AQUA+FLEX tubing is connected. No injuries have been reported to date. However, a disconnected tube in ventilator dependent patients without prompt response to the alarm could lead to serious injury or death. Refer to the firm press release for a complete list of affected lot numbers. Read the complete MedWatch 2010 Safety alert including a link to the firm press release at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm211153.htm | 5/6/2010 3:15 PM | Shujin | | | Vivitrol (naltrexone): Medication Guide Required for Patients | Vivitrol (naltrexone for extended-release injectable suspension): Medication Guide Required for Patients
Audience: Substance Abuse healthcare providers, patients
Alkermes and FDA notified healthcare professionals and patients of an update to the Warnings, Information for Patients, and Dosage and Administration sections of the Prescribing Information to strengthen language regarding the risk of injection site reactions based on postmarketing reports that had been received prior to June 2009. FDA requires that a Medication Guide, which communicates this and other important information about treatment be provided to all patients. Healthcare professionals should also counsel patients about the risks and benefits of Vivitrol before an initial prescription, including those risks and benefits set forth in the new Medication Guide and Prescribing Information, and should ensure that patients understand these risks. Read the complete MedWatch 2010 Safety summary, including links to the Dear HCP letter, the revised Prescribing Information and the new Medication Guide, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm210755.htm | 5/4/2010 5:20 PM | Shujin | | | Baxter Colleague Infusion Pumps: FDA Ordering Recall | Baxter Colleague Infusion Pumps: FDA Ordering Recall
Audience: Hospital Risk Managers
FDA notified healthcare professionals and consumers that it has ordered Baxter to recall and destroy all of its Colleague Volumetric Infusion Pumps (Colleague pumps) currently in use. This action is based on a longstanding failure to correct many serious problems with the pumps. The FDA believes there may be as many as 200,000 of those pumps currently in use. FDA is ordering Baxter to recall and destroy all Colleague infusion pumps, reimburse customers for the value of the recalled device, and assist in finding a replacement for these customers. Hospitals and other users of Baxter’s Colleague pumps will be receiving further instruction and information from Baxter and the FDA regarding their transition. Read the complete MedWatch 2010 Safety alert including links to the FDA News release and previous MedWatch alert, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm210695.htm | 5/4/2010 11:25 AM | Shujin | | | GnRH Agonists: Safety Review of Drug Class Used to Treat Prostate Cancer | GnRH Agonists: Safety Review of Drug Class Used to Treat Prostate Cancer (sold under the brand names Lupron, Zoladex, Trelstar, Viadur, Vantas, Eligard, Synarel, and generics)
Audience: Urology, Oncology healthcare professionals, patients
FDA notified healthcare professionals and patients of FDA's preliminary and ongoing review which suggests an increase in the risk of diabetes and certain cardiovascular diseases in men treated with GnRH agonists, drugs that suppress the production of testosterone, a hormone that is involved in the growth of prostate cancer. Most of the studies reviewed by FDA reported small, but statistically significant increased risks of diabetes and/or cardiovascular events in patients receiving GnRH agonists. FDA's review is ongoing and the agency has not made any conclusions about GnRH agonists and whether they increase the risk of diabetes and cardiovascular disease in patients receiving these medications for prostate cancer. Healthcare professionals and patients should be aware of these potential safety issues and carefully weigh the benefits and risks of GnRH agonists when determining treatment choices. FDA recommends that patients receiving GnRH agonists should be monitored for development of diabetes and cardiovascular disease. Patients should not stop their treatment with GnRH agonists unless told to do so by their healthcare professional. Some GnRH agonists are also used in women and in children for other indications than those above. There are no known comparable studies that have evaluated the risk of diabetes and heart disease in women and children taking GnRH agonists. Read the complete MedWatch 2010 Safety summary, including links to the Ongoing Review document and FDA news release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm210576.htm | 5/3/2010 2:15 PM | Shujin | | | Vita Breath Dietary Supplement | Vita Breath Dietary Supplement
Audience: Consumers, healthcare professionals
FDA notified healthcare professionals, their patients, and consumers not to consume Vita Breath, a dietary supplement manufactured by American Herbal Lab and marketed at health fairs and on the Internet, because the product may contain hazardous levels of lead. The New York City Department of Health and Mental Hygiene analyzed a sample of Vita Breath and reported it contained 1,100 parts per million of lead. This level is more than 10,000 times higher than FDA’s maximum recommended level for lead in candy. People with high blood levels of lead may show no symptoms, but the condition may cause damage to the nervous system and internal organs. Acute lead poisoning may cause a wide range of symptoms, including abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Children are particularly vulnerable to lead poisoning. The FDA is working with state officials in New York and California to further investigate Vita Breath. 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
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm210514.htm | 5/3/2010 1:00 PM | Shujin | | | McNeil Consumer Healthcare Over-the-Counter Infants’ and Children’s Products: Recall | McNeil Consumer Healthcare Over-the-Counter Infants’ and Children’s Products: Recall
including Tylenol, Motrin, Zyrtec, and Benadryl products
Audience: Consumers and healthcare professionals
McNeil Consumer Healthcare and FDA notified healthcare professionals of a voluntary recall of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States, including Tylenol, Motrin, Zyrtec, and Benadryl products. Some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. These products were distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait. See the company Press Release for a list of products affected by this recall. Consumers can contact the company at 1-888-222-6036 and also at www.mcneilproductrecall.com. Read the MedWatch safety summary, including a link to the FDA Questions and Answers web page regarding this recall, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm210442.htm | 5/1/2010 12:30 AM | Shujin | | | Cardiac Science Automated External Defibrillators | Cardiac Science Automated External Defibrillators - Powerheart, Cardiovive, NK, Responder models: Class I Recall
Audience: Emergency Medical Personnel, Risk Managers
[UPDATED 04/27/2010] This update alerts users that Nihon Kohden (NK) and GE Responder models are also affected although they were not identified in earlier communications about this recall. In addition, Cardiac Science issued a software upgrade for the devices’ self tests on 02/24/10 for the Powerheart automatic external defibrillators (Models 9390A and 9390E) and is planning on issuing a similar software upgrade for other affected devices. However, FDA’s review of the updated software indicates that it detects some but not all electrical component defects. Updated recommendations and complete list of affected models can be found in the 04/27/2010 Medical Device Update. Read the complete MedWatch 2010 Safety alert including links to the original Class 1 recall notice and updated recommendations and other information, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm205165.htm | 4/28/2010 10:30 PM | Shujin | | | Coviden Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes |
Coviden Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes
Audience: Emergency medicine, Hospital Risk Managers
FDA and Coviden notified healthcare professionals of a recall of certain lots of its cuffed ShileyTM tracheostomy tubes and Custom/Specialty tracheostomy tubes due to the product’s cuff not holding air as a result of leaks in the pilot balloon inflation assembly. With respect to the affected units, if a cuff does not hold air, ventilation will be adversely affected since the ability to generate positive pressure in the airway could be compromised by lack of cuff seal. This could result in a sudden decrease in the amount of oxygen in the blood or a sudden increase in the amount of carbon dioxide in the blood, especially if the patient requires assisted mechanical ventilation. In some instances, this could result in serious injury, including death. The voluntary recall only affects lot numbers from a specific period of time. Only Shiley tracheostomy tubes from lot numbers listed in the firms' press release are affected by this action. Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm209712.htm | 4/24/2010 6:40 PM | Shujin | | | LIFEPAK 15 Monitor/Defibrillator | LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc.
Audience: Emergency medical personnel, consumers
FDA notified healthcare professionals of a Class I recall of LIFEPAK 15 Monitor/Defibrillator manufactured and distributed between Marcy 26, 2009 and December 15, 2009. There is a potential for the device to unexpectedly:
• Power Off then On by itself.
• Power Off then NOT turn On.
• Power Off by itself requiring the operator to turn it back On.
• Stay powered On and not allow itself to be turned Off.
Healthcare professionals 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.htm1
• 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 Recall Notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm209467.htm | 4/22/2010 7:05 PM | Shujin | | | Propylthiouracil | Propylthiouracil-Boxed Warning Added
Audience: Endocrine healthcare professionals, Pharmacists, Pediatricians
FDA has added a Boxed Warning to the label for propylthiouracil, to include information about reports of severe liver injury and acute liver failure, some of which have been fatal, in adult and pediatric patients using this medication. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to 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 Drug Safety Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm164162.htm | 4/21/2010 2:55 PM | Shujin | | | Camolyn eye drops, Fisiolin nasal drops: Voluntary recall due to non-sterility | Camolyn eye drops, Fisiolin nasal drops: Voluntary recall due to non-sterility
Audience: Consumers, Pharmacists
US Oftalmi and FDA notified healthcare professionals of the nationwide recall of all over-the-counter eye drops and nasal drops, initiated due to conditions at the manufacturing facility that cannot assure the sterility of the products. Products that are non-sterile have the potential to cause eye infections, which may be sight threatening. Products are packaged in 15mL plastic bottles and were distributed nationwide to food and drug distributors. The products affected by this recall with lot numbers, expiration dates and UPC codes are noted in the firm's press release below. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to 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 firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm207794.htm | 4/7/2010 6:50 PM | Shujin | | | Stud Capsule For Men | Stud Capsule For Men: Product contains Undeclared Drug Ingredient
Audience: Consumers, Pharmacists
Kanec USA and FDA notified healthcare professionals of a nationwide recall of Stud Capsule For Men [Lot #060607-01/060108-01, Exp 6-2013], after being informed by FDA that laboratory analysis of a sample found the product to be adulterated with sildenafil, an FDA approved drug. Use of this product may pose a threat to consumers because the analogue 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. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance. The products are sold as a blister pack containing one capsule per unit of use 24-packs in a Box. Lot number and expiration date appears on the seal. Consumers who have this recalled product in their possession should stop using them immediately. Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm207630.htm | 4/7/2010 6:45 PM | Shujin | | | Stalevo (entacapone/carbidopa/levodopa) | Stalevo (entacapone/carbidopa/levodopa)
Audience: Neurology, Oncology, and Family Medicine
FDA notified healthcare professionals and patients that it is evaluating data from a long-term clinical trial called Stalevo Reduction in Dyskinesia Evaluation - Parkinson's Disease (STRIDE-PD), that may suggest that patients taking Stalevo may be at an increased risk for developing prostate cancer. Other controlled clinical trials evaluating Stalevo or Comtan (entacapone) did not find an increased risk of prostate cancer. FDA is still reviewing the available information and has not concluded that Stalevo increases the risk of developing prostate cancer. Healthcare professionals should be aware of this possible risk and follow current guidelines for prostate cancer screening. FDA recommends that healthcare professionals follow the recommendations in the drug label when prescribing Stalevo and Comtan. Patients should not stop taking their medication unless directed to do so by their healthcare professional. Read the complete MedWatch safety summary including a link to the Drug Safety Communication at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm206934.htm | 3/31/2010 4:45 PM | Shujin | | | MasXtreme Capsules (Natural Wellness) | MasXtreme Capsules (Natural Wellness)
Audience: Consumers, Pharmacists
Natural Wellness and FDA notified consumers that MasXtreme, a product sold as a dietary supplement contains aildenafil close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile as well as the drug phentolamine which is an alpha-adrenergic blocker. This may pose a threat to consumers because aildenafil 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. Common side effects of phentolamine include arrhythmia (abnormal heart rhythm) and tachycardia (rapid heart beat). MasXtreme is sold in blister packs containing one (1) capsule. The product is distributed nationwide by Natural Wellness Inc. Consumers who have purchased MasXtreme capsules are urged to immediately discontinue their use. 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/ucm206791.htm | 3/30/2010 7:45 PM | Shujin | | | Rotarix Vaccine: Update | Rotarix Vaccine: Update to Clinicians and Public Health Professionals
Audience: Pediatric and family practice healthcare professionals, public health professionals
FDA is recommending that healthcare professionals temporarily suspend the use of Rotarix, a vaccine used to prevent rotavirus disease. FDA’s recommendation is a precaution taken while the agency learns more about the situation. FDA has learned that DNA from porcine circovirus type 1 (PCV1) is present in Rotarix. PCV1 is not known to cause disease in humans. There is no evidence at this time that this finding poses a safety risk. Because available evidence supports the safety of Rotarix, no medical follow-up is needed for patients who have been vaccinated with Rotarix. There are two licensed vaccines for rotavirus in the United States: RotaTeq and Rotarix. For children who have received one dose of Rotarix, CDC advises that clinicians can complete the series with RotaTeq for the next two doses. Additional information, including information for healthcare professionals and parents, is provided in the document below. Read the complete MedWatch 2010 Safety summary, including a link to the Update statement from FDA, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm205640.htm | 3/23/2010 12:10 AM | Shujin | | | Boston Scientific Implantable Cardioverter Defibrillators: Recal | Boston Scientific Implantable Cardioverter Defibrillators: Recall
Audience: Cardiology healthcare professionals, patients
FDA notified healthcare professionals that FDA has been notified by Boston Scientific that it has stopped shipment and started recalling all of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that have not yet been implanted. FDA is advising practitioners that they should not use these devices unless and until the agency reviews and approves the changes the company has made. FDA is not aware of new safety concerns and, therefore, does not recommend that any of the devices subject to the recall be explanted. Product families included in this advisory include Boston Scientific’s Cognis, Confient, Livian, Prizm, Renewal, Teligen and Vitality. Read the complete MedWatch 2010 Safety summary, including a link to the FDA Statement at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm205409.htm | 3/19/2010 4:05 PM | Shujin | | | Zocor (simvastatin): increased risk of muscle injury with high doses | Zocor (simvastatin): increased risk of muscle injury with high doses
Simvastatin is sold as a single-ingredient generic medication and as the brand-name, Zocor. It is also sold in combination with ezetimibe as Vytorin; and niacin as Simcor.
Audience: Primary care providers, patients
FDA notified healthcare professionals and patients that, based on review of data from a large clinical trial and other sources, there is an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, Zocor (simvastatin) 80 mg, compared to patients taking lower doses of simvastatin and possibly other drugs in the "statin" class. FDA is also reviewing data from other clinical trials, observational studies, adverse event reports, and data on prescription use of simvastatin to better understand the relationship between high-dose simvastatin use and muscle injury. Recommendations for healthcare professionals, recommendations for patients and a data summary of information used in this ongoing review are provided in the Drug Safety Communication. Read the complete MedWatch 2010 Safety summary, including a link to the Safety Communication and current Prescribing Information, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm205404.htm | 3/19/2010 4:00 PM | Shujin | | | Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device: Class I Recall | Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device: Class I Recall including Numerous Products Containing the Q-Syte Luer Access Split Septum Device, Repackaged and Distributed by Acacia Inc. (also known as MPS Acacia), Medical Action Industries, Inc., and Arrow International, Inc.
Audience: Hospital risk managers
FDA notified healthcare professionals of the Class 1 recall of certain lots of the BD Q-Syte Luer Access Split Septum device and other finished products, including kits and trays, sold by other companies in which the Q-Syte Luer Access device is a component. This device is used with other infusion therapy products to administer therapies, such as chemotherapy, blood and fluids into the intravenous system. The affected BD products were distributed from August 1, 2008 through February 1, 2010. These lots of the BD Q-Syte Luer Access Split Septum devices are defective, which may result in air bubbles leaking into the infusion system and into the patient’s bloodstream, resulting in an air embolism. In addition, these defective devices may result in leakage of therapy being infused and result in incomplete inadequate administration of therapy. There is also a potential for blood leakage through this defect. These problems may result in serious injuries or death. For specific information on the affected products, see the list of recalled devices in the appendix of the Initial Communication. Read the complete MedWatch 2010 Safety summary, including a link to the Initial Communication and Recall Notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm205098.htm | 3/18/2010 11:25 PM | Shujin | | | Cleviprex (clevidipine butyrate): Reca | Cleviprex (clevidipine butyrate): Recall
Audience: Pharmacists, risk managers
[UPDATE] The December 2009 recall has been expanded to include four additional lots with the lot numbers and expiration dates noted in the firm press release of March 17, 2010. [Posted 12/17/2009] 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 | 3/18/2010 5:15 PM | Shujin | | | Gyrus ACMI Micron Bobbin Vent Tube T: Class I Recall | Gyrus ACMI Micron Bobbin Vent Tube T: Class I Recall
Audience: Hospital Risk Managers, Surgical Service personnel
FDA and Gyrus ACMI notified healthcare professionals of a Class I recall of Gyrus ACMI Micron Bobbin Vent Tube T, 1.27 mm. This device is implanted for ventilation or drainage of the middle ear. Units of the product in lot number MH136952 have been shipped without being sterilized. This product was manufactured only on December 17, 2009 and distributed only on December 22, 2009. Patients should contact their physicians to discuss symptoms that may result from use of the affected products. Read the complete MedWatch 2010 Safety summary, including a link to the Recall Notice at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204992.htm | 3/17/2010 9:00 PM | Shujin | | | Teleflex Arrow IV Tubing Sets, Accessories, and Embolectomy Catheters: Recall | Audience: Hospital risk managers
Teleflex Incorporated notified healthcare professionals of the recall of all lots of Arrow Select IV Tubing Sets, accessories, and certain lots of arterial embolectomy catheters because it has been determined that product sterility cannot be guaranteed. Testing revealed pin holes in some of the pouches in which the products are packaged, and if product sterility has been compromised, there is a potential for infection, which could lead to serious injury or death. Consumers who have products with the part numbers notice in the firm's press release should stop using and return the items to Arrow International. Customers can find the entire affected product list at www.teleflexmedical.com. Read the MedWatch safety summary, including a link to the firm's Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204532.htm | 3/16/2010 12:05 PM | Shujin | | | Plavix (clopidogrel) | Plavix (clopidogrel): Reduced effectiveness in patients who are poor metabolizers of the drug
Audience: Cardiology healthcare professionals, patients
FDA notified healthcare professionals and patients that a Boxed Warning has been added to the prescribing information for Plavix, an anti-blood clotting medication. The Boxed Warning in the drug label will include information to:
• Warn about reduced effectiveness in patients who are poor metabolizers of Plavix. Poor metabolizers do not effectively convert Plavix to its active form in the body.
• Inform healthcare professionals that tests are available to identify genetic differences in CYP2C19 function.
• Advise healthcare professionals to consider use of other anti-platelet medications or alternative dosing strategies for Plavix in patients identified as poor metabolizers.
Plavix is given to reduce the risk of heart attack, unstable angina, stroke, and cardiovascular death in patients with cardiovascular disease. Plavix works by decreasing the activity of blood cells called platelets, making platelets less likely to form blood clots. A data summary and additional information for healthcare professionals and patients are provided in the linked Drug Safety Communication. Read the complete MedWatch 2010 Safety summary, including a link to the Drug Safety Communication at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204256.htm | 3/12/2010 4:00 PM | Shujin | | | Counterfeit Polypropylene Surgical Mesh | Counterfeit Polypropylene Surgical Mesh: Initial Communication
Audience: Surgical services managers, risk managers
Counterfeit flat sheets of polypropylene surgical mesh, used in the repair of hernias and chest wall defects, are being marketed in the United States, labeled with the C. R. Bard/Davol brand name. These products are not Bard-manufactured products. Healthcare professionals and facilities should carefully examine all manufacturers’ polypropylene surgical mesh products for their lot numbers and anything unusual that might indicate they are counterfeit. The product codes, sizes and lot numbers of the counterfeit product identified, to date, are noted in the linked Initial Communication, and recommendations/actions for healthcare professionals, healthcare facilities, and patients are provided. Healthcare professionals and patients are encouraged to report adverse events, product problems, or suspected counterfeit product 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 Initial Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204224.htm | 3/12/2010 2:55 AM | Shujin | | | Abiomed AB5000 Circulatory Support System: Class I Recall | Abiomed AB5000 Circulatory Support System: Class I Recall
Audience: Cardiovascular surgery healthcare professionals, hospital risk managers, biomedical engineers
FDA notified healthcare professionals of the Class 1 recall of the AB5000 Circulatory Support System, a product that supplies power to disposable blood pumps used to support the left and/or right sides of the heart. The computer may shut down (stop pumping) without an alarm and this defect may cause serious injuries or death. These products were manufactured and distributed between May 2003 and December 2009. Read the complete MedWatch 2010 Safety summary, including a link to the FDA Recall Notice at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm203956.htm | 3/11/2010 6:25 PM | Shujin | | | Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall | Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall
Audience: Cardiology, Hospital Risk Managers
FDA notified healthcare professionals of the Class 1 recall of Torflex Transseptal Guiding Sheath, a medical device used 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. This product was manufactured from April 11, 2007 through March 3, 2008 and distributed from April 2007 through May 2009. Recalled model and lot numbers are noted in the Recall Notice. Read the complete MedWatch 2010 Safety summary including a link to the FDA Recall Notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204177.htm | 3/11/2010 5:50 PM | Shujin | | | Oral Bisphosphonates | Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures
Audience: Orthopedic healthcare professionals, patients
FDA notified healthcare professionals and patients that at this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. FDA is working with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather more information and evaluate the issue further. FDA recommends that healthcare professionals follow the recommendations in the drug label when prescribing oral bisphosphonates. Patients should continue taking oral bisphosphonates unless told by their healthcare professional to stop. Patients should talk to their healthcare professional if they develop new hip or thigh pain or have any concerns with their medications. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204127.htm | 3/11/2010 5:20 PM | Shujin | | | Beckman Coulter UniCel DxC Synchron Clinical System Class I Recall | Beckman Coulter UniCel DxC Synchron Clinical System – Ion Selective Electrode Flow Cell: Class I Recall
Audience: Hospital risk managers, laboratory managers
FDA notified healthcare professionals of the Class I recall of UniCel DxC Synchron Clinical System – Ion Selective Electrode (ISE) Flow Cell. These systems are computer-controlled clinical chemistry analyzers used to determine different types of blood chemistries and other chemistries from blood samples collected from an individual. There may be excessive build-up of protein, bacteria, and sample tube additives in the instrument’s ion selective electrode flow cell which may cause incorrect sodium results. This product has been manufactured and distributed since November 2004. See Recall Notice for serial numbers affected by this recall. Read the complete MedWatch 2010 Safety summary including a link to the FDA Recall notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204106.htm | 3/11/2010 5:15 PM | Shujin | | | WinRho SDF (Rho(D) Immune Globulin Intravenous (Human) | WinRho SDF (Rho(D) Immune Globulin Intravenous (Human): Risk of Intravascular Hemolysis
Audience: Hematological healthcare professionals
Cangene, Baxter and FDA notified healthcare professionals that cases of intravascular hemolysis (IVH) and its complications, including fatalities, have been reported in patients treated for immune thrombocytopenic purpura (ITP) with WinRho SDF. IVH can lead to clinically compromising anemia and multi-system organ failure including acute respiratory distress syndrome. Serious complications including severe anemia, acute renal insufficiency, renal failure and disseminated intravascular coagulation have also been reported. Fatal outcomes associated with IVH and its complications have occurred most frequently in patients of advanced age (age over 65) with co-morbid conditions. The Boxed Warning informs healthcare professionals that:
• Patients should be closely monitored in a health care setting for at least eight hours after administration
• A dipstick urinalysis should be performed at baseline, 2 hours, 4 hours after administration and prior to the end of the monitoring period
• Patients should be alerted to and monitor for signs and symptoms of IVH, including back pain, shaking chills, fever, and discolored urine or hematuria. Absence of these
signs and/or symptoms of IVH within eight hours do not indicate IVH cannot occur subsequently.
• If signs and/or symptoms of IVH are present or if IVH is suspected after WinRho administration, post-treatment laboratory tests should be performed including plasma
hemoglobin, urinalysis, haptoglobin, LDH and plasma bilirubin (direct and indirect).
Read the complete MedWatch 2010 Safety summary, including a link to the Dear Healthcare Professional letter, revised Prescribing Information and Information for Patients document, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm203739.htm | 3/10/2010 5:50 PM | Shujin | | | 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&qu |
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