The Recall Lawyers

Here is the most recent word from the FDA on Avandia and heart attacks. FDA ALERT #1: 5/21/2007, updated 11/19/2007: This update highlights changes to the prescribing information for rosiglitizone including a new BOXED WARNING and changes to the WARNINGS, PRECAUTIONS, and INDICATIONS sections of the label 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. Healthcare professionals should factor this new information into their individual treatment decisions for their patients.

Posted by Louisville, Kentucky lawyer: Larry Jones 1-888-KYLAW22

The Federal Food and Drug Administration issued a safety alert about Avandia (rosiglitazone maleate) on May 21, 2007 after a study in the New England Journal of Medicine linked the very popular diabetes drug to a 43% increase in the risk of heart attack and a 64% increase in the risk of death from all cardiovascular causes. Avandia has been one of GlaxoSmithKline's best selling drugs. Over 6 million American consumers have used the drug to treat adult onset, type 2 diabetes.

Avandia's History

The FDA approved Avandia in 1999 for treatment of type 2 diabetes, a serious and life threatening disease that affects about 18 to 20 million Americans. Diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation. Since the drug was approved by the FDA, it has been monitoring several heart-related adverse events (e.g., fluid retention, edema and congestive heart failure) based on signals seen in previous controlled clinical trials of Avandia. The FDA has updated the product's labeling on several occasions to reflect these new data, most recently in 2006. The most recent labeling change for Avandia also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia. This new warning was based on the result of a controlled clinical trial in patients with existing congestive heart failure.