Two New Studies Reiterate Avandia Risks, Findings to be Considered
in FDA’s decision on fate of GSK’s controversial drug.

Two studies made public on Monday, June 28, 2010, have reiterated earlier findings that Avandia significantly increases the risk of heart attack, stroke or death. The studies were published in two influential medical journals: the Journal of the American Medical Association (JAMA) and the Archives of Internal Medicine.

The articles have been released early in an effort to influence an expert panel due to convene on July 13 and 14 to discuss the future of GSK’s diabetes drug. The panel will meet with the Food and Drug Administration to discuss whether or not Avandia should be removed from the market.

The article published in JAMA compared the risks associated with both Avandia and the similar diabetes drug Actos (made by Takeda). Researchers found that heart-related risks associated with Avandia were significantly higher than those associated with Actos. In an editorial released alongside the study, researchers argued that because of the risks involved with Avandia, there was no reason to prescribe the drug over its safer and equally effective counterpart, Actos.

The study to be published in the Archives of Internal Medicine was co-authored by Dr. Steven E. Nissen, who has been at the forefront of the Avandia controversy since he published a 2007 study linking Avandia to increased heart risks. This recent study is an updated version of that 2007 study with more patients and more data. Three years after his trail blazing study, Dr. Nissen has come to the same conclusions – Data shows that Avandia increases the risks of heart attack by 39 percent and the risks of heart-related death by 46 percent.

Scientists hope that these damning studies will have an impact on the experts and FDA officials who will soon decide the fate of the controversial diabetes drug. Upon learning of the two compelling studies, FDA’s principal deputy commissioner Dr. Joshua M. Sharfstein said, “these are two important papers that will be part of the discussion that F.D.A. has as we consider the important question of Avandia’s safety.”

New York Times, June 28, 2010: Heart Risks Seen in Diabetes Medicine


Return to Avandia News Menu