US considers lifting safety limits on blockbuster diabetes pill

A former blockbuster diabetes pill which was subjected to major US safety restrictions in 2010 may not be as risky as once thought, according to the latest analysis of the much-debated GlaxoSmithKline drug Avandia.

The Food and Drug Administration is reviewing a new interpretation of the key study of Avandia’s heart attack risks, which suggests 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 restrictions on its use.

The positive safety review from Duke University researchers is the latest twist in a years-long debate over Avandia, which has divided medical experts, cost Glaxo billions of dollars and possibly resulted in an unknown number of patient heart attacks.

First approved in 1999, Avandia became the top-selling diabetes pill in the world by 2006 with sales of $3.4 billion. But prescriptions plummeted the following year after an analysis of dozens of studies suggested Avandia could raise the risk of heart attack.

For three years the FDA struggled to answer a seemingly simple question: Does Avandia increase the risk of heart attacks? A definitive answer has never been reached, in part because patients with diabetes are already predisposed to heart problems. That makes it extremely difficult to tell which heart attacks are drug-related and which are simply a result of the underlying disease.

Finally in 2010 the FDA decided to restrict the drug’s use to all but the rarest of cases. Regulators in Europe banned the drug outright.

FDA critics have speculated that the real purpose of this week’s meeting is to vindicate FDA officials who kept Avandia on the market for so many years. They say regulators appear poised to roll back safety limits on the drug.

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