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 […]
Bush Republicans Keep Insurance Companies Healthy
Bush Republicans Keep Insurance Companies Healthy With Bush Republicans in the Senate seeking to use their “health” week to push Medical Malpractice legislation that will do nothing to fix the health care crisis in America today, Senate Democratic Leader Harry Reid delivered the following remarks on the Floor of the U.S. Senate. The text […]
FDA Updates Regarding Voluntary Market Withdrawal of Bausch & Lomb ReNu MoistureLoc® Contact Lens Solution
FDA Updates Regarding Voluntary Market Withdrawal of Bausch & Lomb ReNu MoistureLoc® Contact Lens Solution Update on Serious Eye Infections Associated with Soft Contact Lens Use and Contact Lens Solution May 5, 2006. As reported in the MMWR, patients with confirmed cases of Fusarium keratitis have reported using various contact lens cleaning solutions including various types of ReNu […]