Avandia Information
What is Avandia?
Avandia, generically known as rosiglitazone, is a drug used to help Type 2 diabetes patients with insulin resistance. Manufactured by GlaxoSmithKline, Avandia is in the thiazolidinedione (TZD) class of drugs, which are the first class of medications designed to reverse the basic problem in Type 2 diabetes of resistance to insulin. In May 2007, the New England Journal of Medicine published an analysis linking Avandia to increased risk of heart attacks. The meta-analysis reviewed 42 studies and found patients taking Avandia to be at a 43% higher risk of heart attacks.
- FDA Adds to Avandia Black Box Warning In November 2007
- The U.S. Food and Drug Administration announced on November 14, 2007 that the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add a new black box warning on the drug's labeling about potential increased risk for heart attacks. This increased risk is unique to Avandia and not associated with other drugs in the same class.
- FDA's Weak Response To May 2007 News That Avandia Increases The Risk Of Heart Attacks And Cardiovascular Deaths
- The findings from a new meta-analysis by Nissen and Wolski are disturbing insofar that they show patients taking Avandia had a 43% higher risk of heart attacks and a 64% elevated rate of cardiovascular death. The FDA's analysis of all available Avandia data is ongoing and at this time the agency is not asking GlaxoSmithKline to recall Avandia, suspend sales, nor take any other particular action.
- May 2007 New England Journal Of Medicine Article Links Avandia to Risk Of Heart Attack, Or Myocardial Infarction
- In their article, "Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes", Steven E. Nissen, M.D., and Kathy Wolski, M.P.H., report on a meta-analysis of data from 42 clinical trials that found a 43% increased risk of heart attack among Type 2 diabetics treated with Avandia (rosiglitazon). This Avandia - heart attack article was published online by the New England Journal of Medicine (NEJM) on May 21, 2007; the article will appear in the June 14, 2007 print edition of this leading medical journal.
- Avandia Class Actions
- We believe that people who have suffered a serious injury or died from Avandia side effects are better served when an individual lawsuit is filed on their behalf. A serious injury or death case should not be filed as part of any Avandia class action together with the claims of many other people who may have had different injuries caused by Avandia.
- Avandia and Legal Compensation
- Statutes of limitations can prevent obtaining legal compensation for Avandia side effects causing personal injury or death. If you experienced serious side effects from the use of Avandia, or a person died due to an adverse reaction while taking Avandia, you may have a claim for legal compensation. Legal compensation claims involving an Avandia-related disease or death caused by Avandia are usually made by filing an individual lawsuit as opposed to a class action.
- Free Avandia Case Evaluation
- FDA Adds to Black Box Warning on Avandia November 2007
- This update highlights changes to the prescribing information for rosiglitizone including a new warning about the potential increased risk of myocardial ischemia. FDA also has requested that the manufacturer, GlaxoSmithKline, develop a Medication Guide for patients that provides information about the safe use of rosiglitazone.
- FDA Avandia Alert May 2007
- FDA notification to healthcare professionals about potential for significant increase in heart attack risk for Avandia patients.
- FDA Safety Alert for Avandia: May 21, 2007
- Recently, the manufacturer of Avandia provided FDA with a pooled analysis (meta analysis) of 42 randomized, controlled clinical trials in which Avandia was compared to either placebo or other anti-diabetic therapies in patients with type 2 diabetes. The pooled analysis suggested that patients receiving short-term (most studies were 6-months duration) treatment with Avandia may have a 30-40 percent greater risk of heart attack and other heart-related adverse events than patients treated with placebo or other anti-diabetic therapy. These data, if confirmed, would be of significant concern since patients with diabetes are already at an increased risk of heart disease.
- Avandia Prescribing Information
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