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FDA Reconsidering Avandia Restrictions

Jun 3, 2013

The knell appeared to sound for Avandia a few years ago when federal health officials decided to almost ban the drug outright because it had been linked to myriad health problems.

Today, the U.S. Food and Drug Administration (FDA) is appearing to go back on those restrictions as the agency is asking a panel of experts to review the information available on the drug and decide whether Avandia should be more widely obtainable again, according to a report from The New York Times.

The FDA advisory committee has been tapped by the agency to examine whether it went too far in restricting Avandia nearly three years ago. At that time, according to our previous reports, the FDA didn’t fully remove Avandia from the market as a viable type 2 diabetes medication but restrictions placed on access to the drug essentially deemed it a final resort for diabetics who had run out of other effective treatments.

To get Avandia, a patient and doctor would have to sign off on a waiver that stated they were aware of the potential for serious and possibly fatal side effects that could result. At the height of its popularity, Avandia had accounted for more than $3 billion in annual sales for its maker, GlaxoSmithKline, according to our reports.

Based on previous examples, an advisory committee may determine one result but the FDA is not compelled to follow that advice. That means if the advisory committee votes in favor of loosening the restrictions on Avandia, the FDA does not have to work in lockstep with that direction and could still keep these current restrictions in place.

In 2009, the FDA ordered GlaxoSmithKline to commission an independent study on Avandia to determine if there was a fatal heart attack risk linked to the drug as numerous other studies had shown. The record trial eventually showed there was no link between the drug and the side effect but the FDA publicly criticized the means by which the drug company conducted the research, and a year later had ultimately severely restricted access to it. In the study, at least a dozen people taking Avandia had suffered a life-threatening heart condition but GlaxoSmithKline omitted this evidence from study results, according to our previous reports.

The New York Times reports that the FDA even considering allowing Avandia back on the market is unusual and almost unprecedented. The chances of Avandia making such a return seem unlikely, based on this report.

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