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Avandia critic testifies at hearing

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Published: June 6, 2007 at 2:07 PM

WASHINGTON, June 6 (UPI) -- A potential heart attack risk linked to Avandia is "particularly concerning" since the drug is used by diabetics, a U.S. doctor told lawmakers Wednesday.

Testifying on Avandia safety before the House Committee on Oversight & Government Reform, Cleveland Clinic cardiologist Steven Nissen told lawmakers 65 percent to 80 percent of all diabetic deaths stem from heart attack.

Nissen was the first to cast doubt on the drug's cardiovascular safety when he performed a meta-analysis of 40 studies that he said suggest a 43-percent greater risk of heart attack in patients using the widely prescribed drug.

Food and Drug Administration representatives, who are also testifying at Wednesday's hearing, are mulling whether to add a black box warning to GlaxoSmithKline's drug.

FDA officials told lawmakers they have asked Takeda, maker of same-class type 2 diabetes drug Actos, to perform its own meta-analysis of Actos studies to assess that drug's heart safety profile.

When the possible heart signal with Avandia first came to light, many patients taking Avandia were switched over to Actos.

Meanwhile, Glaxo has mounted an aggressive P.R. blitz in defense of its blockbuster drug, blasting Nissen's conclusions and pointing to interim data from its own RECORD study of Avandia showing that the therapy's heart attack risk was roughly on par with other therapies.

Glaxo CEO J.P Garnier was quoted Wednesday on CNBC saying Avandia was not destined to be "the next Vioxx."

© 2007 United Press International, Inc. All Rights Reserved. Any reproduction, republication, redistribution and/or modification of any UPI content is expressly prohibited without UPI's prior written consent.

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