AVANDIA HEART ATTACKS

THE FDA HAS ANNOUNCED A SAFETY ALERT FOR PATIENTS USING AVANDIA
Avandia is a diabetes drug which was approved 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. FDA is aware of a potential safety issue related to rosiglitazone maleate (Avandia). Safety data from a pooled analysis of controlled clinical trials have shown a significant increase in the risk of an Avandia heart attack and heart-related deaths in patients taking Avandia.  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.

FDA has not confirmed the clinical significance of the reported increased risk of ischemic cardiovascular events in the context of other studies. Myocardial ischemic events are currently described in the WARNINGS section of the rosiglitzsone label. FDA does not know whether the other approved medication in the same pharmacologic class or other oral drugs for treating type 2 diabetes have less, the same, or greater risks. Switching diabetic patients to other therapies also confers its own risks. For those reasons, FDA is providing this emerging information to prescribers so that they and their patients can make individualized treatment decisions.

This information reflects FDA’s current analysis of available data concerning this drug. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug product and the emerging drug safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing the product. FDA is considering, but has not reached a conclusion about, whether this information warrants any regulatory action. FDA intends to update this sheet when additional information or analyses become available.

If you or someone you know has suffered an Avandia heart attack or other serious injury contact us today to explore your legal options.