Disability Happens ™

FDA Warnings

1. FDA Approves New Formulation of Coagulation Therapy - he U.S. Food and Drug Administration has approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years.
2. FDA Approves First Generic Ropinirole - The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.
3. FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products - The U.S. Food and Drug Administration's final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" has detected hazardous amounts of chromium.
4. Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction - Device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to Automatic External Defibrillators (AEDs) manufactured by Physio-Control, Inc.
5. FDA Embarks on Major Hiring Initiative for its Public Health Mission - The FDA is hiring hundreds of individuals with science and medical backgrounds to help meet the agency's responsibilities to assure the safety and/or efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation.
6. FDA Approves Amitiza for IBS-C - The U.S. Food and Drug Administration has approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over.
7. Coronary Artery Plaque Imaging Device Cleared by FDA - The U.S. Food and Drug Administration has cleared for marketing a device that a doctor can use to see inside a blood vessel to assess the fat content of the plaque which builds up on the wall of the coronary arteries.
8. FDA Approves Relistor for Opioid-Induced Constipation - The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain.
9. FDA Orders Pet Food Maker to Obtain Emergency Operating Permit - The U.S. Food and Drug Administration issued an order requiring that Evanger's Dog and Cat Food Co., Inc., in Wheeling, Ill., obtain an emergency permit from the FDA before its canned pet food products enter interstate commerce.
10. FDA Proposes Recommendations for Two Animal Drug Funding Programs - The U.S. Food and Drug Administration has delivered recommendations to Congress for two programs that provide funding for the review of pioneer and generic animal drugs.

FDA Recalls

1. New Medical Products: FDA Licenses New Hemophilia Treatment - FDA recently licensed a new treatment for hemophilia A called Xyntha. Xyntha, which is made by Wyeth Pharmaceuticals, is a genetically engineered version of factor VIII, a protein essential for blood clotting that is decreased or absent in patients ...
2. Recalls and Safety Alerts: Unsafe Use of Extended-Release Tussionex Suspension - FDA is cautioning healthcare professionals, patients and caregivers about the unsafe use of Tussionex Pennkinetic Extended-Release Suspension. This product is a long-acting cough suppressant containing hydrocodone, a narcotic antitussive, and chlorp...
3. Recalls and Safety Alerts: Liver Injury with Tysabri - Biogen Idec and Elan Pharmaceuticals are warning healthcare professionals about reports of clinically significant liver injury in patients taking Tysabri (natalizumab). Tysabri is a monoclonal antibody used to treat certain patients with relapsing f...
4. Recalls and Safety Alerts: Updated Labeling Changes for Tamiflu and Relenza - Roche Laboratories has updated information on neuropsychiatric events for Tamiflu (oseltamivir phosphate), a drug that's used to treat or prevent influenza in patients 1 year and older. The revised labeling reminds practitioners that some patients...
5. Recalls and Safety Alerts: New Instructions for Using Talecris IG Syringes - Talecris Biotherapeutics has revised the directions for administering some of the company's immune globulin products -- ones that come in uncalibrated prefilled 2 mL syringes with fixed needles. The products are HyperRAB? S/D , which is an anti-rabi...
6. Recalls and Safety Alerts: Hepatotoxicity with Prezista - FDA and Tibotec Therapeutics are alerting healthcare professionals about the risk of hepatotoxicity associated with the antiretroviral drug Prezista (darunavir). Prezista, co-administered with ritonavir and other antiretroviral agents, is used to tr...
7. Recalls and Safety Alerts: Information on Mortality Rates with the AneuRx? Stent Graft System - In a recent Public Health Notification, FDA informed healthcare professionals about new data on mortality rates associated with the AneuRx? Stent Graft System. This endovascular graft, made by Medtronic, is used as an alternative to open surgery in ...
8. Preventing Medical Errors: Mistakenly Swallowing Inhaler Capsules - FDA has issued an advisory about the danger of mistakenly swallowing Spiriva (tiotropium bromide inhalation powder) and Foradil (formoterol fumarate inhalation powder) inhalation capsules. These capsules are intended to be used with inhalation devic...
9. Patients Are Asking: Choosing the Correct Test Strip for a Blood Glucose Meter - FDA is aware of cases where patients have used LifeScan OneTouch Ultra test strips with their Abbott Precision Xtra blood glucose meters. As a result, the meters recorded lower-than-expected blood glucose levels, which can have serious clinical ...

FDA Consumer Updates

1. Combating Antibiotic Resistance - Misuse and overuse of antibiotics have contributed to antibiotic resistance, a phenomenon that reduces or eliminates the effectiveness of antibiotics.
2. Device Identifies Fatty Deposits in Coronary Arteries - A new medical device allows doctors to see the plaque buildup on the wall of coronary arteries. Many heart attacks occur when a fatty coronary plaque ruptures, forming dangerous blood clots.
3. Drug Approved for Irritable Bowel Syndrome with Constipation - FDA has approved Amitza (lubiprostone) for the treatment of irritable bowel syndrome with constipation in adult women aged 18 and over
4. Strengthening Beef Safety - An FDA regulation further protects consumers of beef against mad cow disease.
5. New Type of Latex Glove Cleared - FDA has cleared a new type of latex glove that may prove to be a safer alternative for some people with sensitivity to latex.
6. Use Eye Cosmetics Safely - April is Women's Eye Health and Safety Month. Here are tips from FDA about storing, applying, wearing, and removing eye cosmetics.
7. Salmonella Illnesses May be Linked to Recalled Cereal - At least 23 people in 14 states have been diagnosed with salmonellosis that was caused by the same strain of Salmonella found in the recently recalled unsweetened Puffed Rice and unsweetened Puffed Wheat Cereals produced by Malt-O-Meal
8. Find the Latest Drug Product and Safety Information - Resources for keeping up with the latest drug safety information from FDA.
9. A Guide to Drug Safety Terms at FDA - This guide offers descriptions of some of the more common drug safety terms used by FDA throughout the life cycle of a drug.
10. Civil Penalties Sought Against Maker of Hearing Aid - A hearing aid manufacturer breaks the law, and FDA is seeking more than $2 million in penalties