Avandia recall was nearly issued by FDA
The Wall Street Journal reports today that an internal FDA board narrowly voted earlier this month against an Avandia recall. The federal drug regulators appear to be preparing a “black box” warning about the risk of heart attacks instead of removing the diabetes drug from the market.
>>INFORMATION: Avandia Heart Risks
Avandia has been the center of controversy since May 2007, when a study published by the New England Journal of Medicine found that Avandia side effects increase the risk of heart attacks by 43%. The FDA’s own analysis found a 38% increased risk and many experts estimate that over 100,000 heart attacks could have been caused by Avandia since it was introduced in 1999.
In July 2007, an advisory panel consisting of outside experts was convened by the FDA to evaluate the risks associated with Avandia and review what actions should be taken by the agency to protect the public. Although the panel voted 20 to 3 that the drug does increase the risk of heart attacks, they did not believe that sufficient evidence exists at this time to recommend an Avandia recall. Instead the advisory panel recommended that stronger warnings be added to the diabetes drug.
The FDA is not required to follow the recommendations of their advisory panels, but they usually do. There has been a lot of debate among FDA officials about the safety of Avandia, many public interest groups were calling for an Avandia recall since the drug would likely not be approved today based on the information which is now known.
The Wall Street Journal article published today indicates that the internal vote of the FDA drug-safety oversight board was only 8 to 7 against an Avandia recall. Therefore, the drug will still be available, despite the increased risk of heart attacks. However, the black box warning will now provide information so that doctors and patients can make their own decision about whether the benefits of the diabetes drug outweigh the heart risks.
The lawyers at Saiontz & Kirk, P.A. are reviewing potential Avandia lawsuits nationwide for users of the diabetes drug who have suffered a heart attack, stroke, congestive heart failure or death. The manufacturer, GlaxoSmithKline PLC, has failed to adequately warn of the heart attack risks and could have prevented many serious injuries and deaths if they had acted responsibly. To review a potential claim, request a free claim evaluation by our Avandia lawyers.