Year: 2007

Minnesota health officials investigate illnesses at Quality Pork Processors in Austin; No evidence to suggest general public or food supply at risk

Minnesota health officials investigate illnesses at Quality Pork Processors in Austin; No evidence to suggest general public or food supply at risk 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 […]

FDA Adds Boxed Warning for Heart Attacks to Anti-Diabetes Drug Avandia; Agency says drug to remain on market, while safety assessment continues

FDA Adds Boxed Warning for Heart Attacks to Anti-Diabetes Drug Avandia; Agency says drug to remain on market, while safety assessment continues 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 […]

Defribrillator leads recall: Sprint Fidelis lead fractures

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 unnecessary shocks or may not function at all. Issues with the leads was first noted in March and physicians were notified. Data […]

FDA: Statement on Medtronic’s Voluntary Market Suspension of Their Sprint Fidelis Defibrillator Leads

FDA: Statement on Medtronic’s Voluntary Market Suspension of Their Sprint Fidelis Defibrillator Leads 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 […]

Defect in Sprint Fidelis Defibrillation Leads; Medtronic Halts Distribution

Defect in Sprint Fidelis Defibrillation Leads; Medtronic Halts Distribution 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 […]

Study: diabetics better off avoiding new drugs in favor of cheaper, safer old ones

Study: diabetics better off avoiding new drugs in favor of cheaper, safer old ones 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 […]

FDA Issues Safety Alert on Avandia

FDA Issues Safety Alert on Avandia 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 […]

Driving while asleep among risks of sleeping pills

Driving while asleep among risks of sleeping pills The FDA recently demanded stricter warnings on the labels of various prescription sleep medications in response to some alarming side-effects. Most notably, some sleeping pill patients have been driving in their sleep; in addition to sleep-driving, those on sleep medications are also completing other “complicated activities” while […]

FDA Requests Label Change for All Sleep Disorder Drug Products

FDA Requests Label Change for All Sleep Disorder Drug Products 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 […]

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