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September 18th, 2008. Smoking cessation drug Chanitx has been under scrutiny in recent months as links to dangerous side effects emerge. Made by drug manufacturer Pfizer, Chanitx was approved by the FDA in 2006 and quickly became a top seller, amassing $883 million its first year on the market. Chantix Timeline May ... [More >>]
February 1st, 2008. (Press Release) The U.S. Food and Drug Administration (FDA) today issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline), a prescription medication used to help patients stop smoking. On Nov. 20, 2007, FDA issued an Early Communication to the public and ... [More >>]
November 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 >>]
October 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 >>]
October 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 >>]
October 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 >>]
July 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 >>]
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 >>]
May 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 >>]
March 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 >>]
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Last Updated: March 02, 2009. 11:04:44 am
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