FDA considers lifting safety limits on diabetes pill Avandia
6/3/2013WASHINGTON — A former blockbuster diabetes pill that is subject to major safety restrictions may not be as dangerous as once thought, according to the latest analysis of the much-debated GlaxoSmithKline drug.
The Food and Drug Administration is reviewing a new interpretation of Avandia’s heart attack risk, which suggests that the drug is as safe as older diabetes drugs. At a highly unusual meeting this week, the FDA will ask a panel of experts to vote on a range of options for the drug, including lifting safety restrictions on its use.
The safety review is the latest twist in a years-long debate over Avandia that has divided medical experts. The drug was approved in 1999 and grew into a blockbuster, but regulators restricted its use due to unresolved safety questions in 2010.