Avandia :: Safety alert on Avandia – a timely action of FDA

The U.S. Food and Drug Administration (FDA) issued a safety alert on Avandia, diabetes drug approved to treat type 2 diabetes. I believe safety alert on Glaxo’s diabetes drug Avandia is a timely action by US FDA health agency, remarked Dr. Anil Singhal.

Glaxo defended the drug safety of its diabetes drug Avandia saying “The suggestion that GlaxoSmithKline has placed patients at risk and attempted to silence independent investigation of data is absolutely false. Any fair examination of the company?s record will show that GSK has been fully transparent in its efforts to thoroughly study the safety and effectiveness of Avandia, and to widely communicate that information to governments, scientists, physicians, and the public in the best interests of both patients and scientific debate.”

GSK strongly disagrees with the conclusions reached in the New England Journal of Medicine (NEJM) article, which are based on incomplete evidence and a methodology that the author admits has significant limitations.

Avandia was approved in 1999 for treatment of type 2 diabetes, a serious and life threatening disease that affects about 18 to 20 million Americans and more than 70 million people worldwide. Diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation. Since the drug was approved, FDA 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 alone and in combination with other drugs, and from postmarketing reports.

Just to hide Avandia’s risk factors, Glaxo published a clinical study in late 2006, appreciating Avandia’s clinical safety and performance in reducing blood sugar levels in type 2 diabetes patients. Because of inadequate warnings about Avandia and massive advertising campaigns, its popularity has grown so that 11 million prescriptions were filled for the drug in the United States in 2006 alone.

According to the American College of Cardiology, American Diabetes Association and American Heart Association, this NEJM study deserves serious thought and follow-up. As estimated here, the overall level of the risk associated with rosiglitazone appears to be small, but nonetheless one that must be considered carefully.

In the meantime, patients using this drug should talk to their health care provider to determine the most appropriate course of action. Patients should not stop taking any prescribed medications without first discussing the issue with their health care provider. Further research will be needed in this area to provide conclusive evidence.

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