Archive for 2007Minnesota health officials investigate illnesses at Quality Pork Processors in Austin; No evidence to suggest general public or food supply at riskDecember 3rd, 2007. (Press Release) The Minnesota Department of Health (MDH) is investigating a cluster of 11 cases of neurological illness in workers at Quality Pork Processors, Inc. (QPP) in Austin, Minn. QPP staff and physicians in the Austin and Rochester area recently realized there had been a pattern of cases of ... [More >>] FDA Adds Boxed Warning for Heart Attacks to Anti-Diabetes Drug Avandia; Agency says drug to remain on market, while safety assessment continuesNovember 14th, 2007. (Press Release) The U.S. Food and Drug Administration announced today that the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add new information to the existing boxed warning in the drug's labeling about potential increased risk for heart attacks. People with type 2 diabetes who have ... [More >>] Defribrillator leads recall: Sprint Fidelis lead fracturesOctober 24th, 2007. Distribution of two types of defibrillators, Implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds), is being suspended by Medtronic as a result of lead fractures. If a lead fractures, defibrillators may deliver unecessary shocks or may not function at all. Issues with the leads was first ... [More >>] FDA: Statement on Medtronic’s Voluntary Market Suspension of Their Sprint Fidelis Defibrillator LeadsOctober 22nd, 2007. (Press Release) Statement by Daniel Schultz, M.D., director of the Center for Devices and Radiological Health: Medtronic's decision to voluntarily remove its Sprint Fidelis defibrillation leads from the market is in the best interest of patient safety. These electronic wires are prone to fracture in a small number of patients which ... [More >>] Defect in Sprint Fidelis Defibrillation Leads; Medtronic Halts DistributionOctober 19th, 2007. (Press Release) On Monday, October 15, Medtronic, Inc. said voluntarily suspended worldwide distribution of the Sprint Fidelis® family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949). The Sprint ... [More >>] Study: diabetics better off avoiding new drugs in favor of cheaper, safer old onesJuly 17th, 2007. A new study published in the Annals of Internal Medicine finds that most type-2 diabetics are better off using older, cheaper diabetes drugs than their heavily advertised, newer counterparts. With the exception of those who cannot tolerate specific drugs like Glucophage (metformin), the effectiveness of the older medications was on ... [More >>] Failure-to-warn? Avandia may increase risk of heart attack by 43%June 29th, 2007. One million type two diabetics in the US, and nearly 6 million worldwide, who take Avandia (rosiglitazone maleate) may be putting themselves at an increased risk of heart attack. Earlier this spring, The New England Journal of Medicine released a study by Dr. Steven Nissen that analyzed the combined results ... [More >>] FDA Issues Safety Alert on AvandiaMay 21st, 2007. (Press Release) The U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosiglitazone), a drug approved to treat type 2 diabetes. Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths ... [More >>] Driving while asleep among risks of sleeping pillsMarch 15th, 2007. Drugs included in the label warning update are the following 13 products: Ambien/Ambien CR (Sanofi Aventis) Butisol Sodium (Medpointe Pharm HLC) Carbrital (Parke-Davis) Dalmane (Valeant Pharm) Doral ... [More >>] FDA Requests Label Change for All Sleep Disorder Drug ProductsMarch 14th, 2007. (Press Release) The U.S. Food and Drug Administration (FDA) has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include ... [More >>] |
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