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 […]
Zyprexa & Diabetes (Olanzapine)
Zyprexa & Diabetes (Olanzapine) Injured by Zyprexa? Side effects of this antipsychotic drug include diabetes, weight gain, hyperglycemia, pancreatitis, and diabetic ketoacidosis. Zyprexa Risks The following are the risks and side effects associated with Zyprexa therapy. This list is not exhaustive. From the FDA web site, Zyprexa’s risks include: A life-threatening nervous system problem called neuroleptic […]
Serious Eye Infections Prompt Bausch & Lomb To Withdraw ReNu MoistureLoc® Contact Lens Solution From Market
Serious Eye Infections Prompt Bausch & Lomb To Withdraw ReNu MoistureLoc® Contact Lens Solution From Market Damage May Require Corneal Transplant Patients who wear soft contact lenses should be aware of an increasing number of reports of rare but serious fungal eye infection that can cause permanent blindness. The infection, Fusarium keratitis, has been reported […]