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FDA to consider new study on diabetes drug

WASHINGTON -- A former blockbuster diabetes pill that was subjected to major safety restrictions in 2010 may be less risky than 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 yearslong debate over Avandia, which has divided medical experts, cost Glaxo billions of dollars and possibly resulted in an unknown number of patient heart attacks.

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

"It's the wrong reason to take a regulatory action," said Dr. Steven Nissen of the Cleveland Clinic, who authored the 2007 analysis that first raised public safety concerns about Avandia. "You want to take a regulatory action because it's going to benefit patients. I don't see how patients could possibly benefit from lifting these regulatory restrictions."

Nissen says he requested time to make a formal presentation during the meeting but was turned down by FDA officials.

The FDA says Wednesday's and Thursday's meeting was prompted by a new analysis of the lone study of Avandia's heart risks.

The results were first reported in 2009 and medical experts have been debating their legitimacy ever since. -- AP


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