Tags: US | Diabetes | Pill | FDA

FDA Panel: Diabetes Drug Should Stay on Market

Wednesday, 14 Jul 2010 06:53 PM

 

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A majority of federal health experts has voted to keep the controversial diabetes pill Avandia on the market despite evidence that it increases the risk of heart attack.

A panel of Food and Drug Administration advisers voted 20-12 against withdrawing GlaxoSmithKline's once-blockbuster drug. Panelists who voted to keep the drug on the market were split between several options, including adding new warning labels and restricting use of the drug.

The Food and Drug Administration has convened the panel to help untangle reams of conflicting data over whether the GlaxoSmithKline drug increases heart risks.

Despite an earlier vote that Avandia increases heart risks, panelists said the evidence wasn't strong enough to remove it from the market.

THIS IS A BREAKING NEWS UPDATE. Check back soon for further information. AP's earlier story is below.

WASHINGTON (AP) — Federal health experts said Wednesday the much-debated diabetes pill Avandia increases the risk of heart attack compared to other diabetes drugs.

A majority of 33 expert panelists said the former blockbuster drug is riskier than older diabetes medicines, including its closest competitor.

The Food and Drug Administration has convened the panel to help untangle reams of conflicting data over whether the GlaxoSmithKline drug increases heart risks.

The panel is considering a series of questions culminating with a vote on whether Avandia should be withdrawn from the market.

The FDA is not required to follow the group's advice, though it often does. A final decision will be made in coming months.

Avandia has been under federal scrutiny since 2007, when an analysis first suggested it might cause heart attack.

The FDA has been down this road before. Three years ago a similar FDA panel voted to keep Avandia on the market and the FDA responded by adding bolder warning labels to the drug.

"In terms of what has changed since 2007, I think the totality of evidence is much stronger," said panelist Clifford Rosen of the Maine Medical Research Institute. "It's still not absolute but it's stronger. Clearly there is a signal."

The panel voted 21-4 that Avandia is more likely to cause heart attack than its closest competitor Actos. Eight panelists said there was not enough information to make a decision.

"While I'm not persuaded by the evidence to implicate the drug, I'm also not reassured by the evidence to exonerate it," said Dr. Sanjay Kaul of Cedars-Sinai Medical Center in Los Angeles.

The FDA first approved Avandia in 1999 and it quickly became the top-selling diabetes pill in the world. U.S. sales have plummeted from $2.2 billion in 2006 to $520 million last year as safety concerns swirled around the drug.

Since diabetics are already predisposed to heart risks it is extremely difficult to tell which heart attacks are drug-related and which are simply a result of the underlying disease.

The task of evaluating the possible side effects has dragged on for years without definitive answers.

© Copyright 2014 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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