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  • greenvally_2000 greenvally_2000 Jul 30, 2007 8:36 PM Flag

    Avandia to remain on the market..........

    Panel Votes To Keep Avandia On Market
    Diabetes Drug Maker Disputes Link To Heart Attacks

    UPDATED: 2:54 pm PDT July 30, 2007



    WASHINGTON -- The widely used diabetes drug Avandia should remain on the market, government health advisers recommended Monday, saying evidence of an increased risk of heart attack doesn't merit removal.

    The nonbinding recommendation to the Food and Drug Administration came on a majority vote by the panel. The tally wasn't immediately available.

    "We're being asked today to take a very draconian action based on studies that have very significant weaknesses and are inadequate for us to make that kind of decision," said Rebecca Killion, a Bowie, Md., diabetic and the panel's patient representative.


    However, in an earlier 20-3 vote, the panelists said that available data show the drug does increase heart risks. Panelists said the drug's warning label should be updated and there should be additional study.

    Earlier, a Food and Drug Administration expert said those risks, combined with no unique short-term benefits in helping diabetics control blood-sugar levels, fail to justify keeping Avandia on the market, according to a copy of a slide presentation by Dr. David Graham.

    The document was distributed at the onset of a daylong meeting of a joint panel of outside experts convened to consider whether the drug should be restricted to use in select patients and branded with prominent warnings or removed altogether from sale.

    Previously, the FDA said information from dozens of studies of the GlaxoSmithKline PLC drug points to an increased risk of heart attack.

    However, officials at GlaxoSmithKline cited their own analyses of studies, calling the data inconsistent. They said the research offers no overall evidence of differences with other diabetes drugs when it comes to heart risks.

    "The number of myocardial infarctions is small, the data are inconsistent and there is no overall evidence rosiglitazone is different from any other oral antidiabetes agents," said Dr. Ronald Krall, the company's senior vice president and chief medical officer.

    The FDA isn't required to follow the advice of its advisory committees but usually does.

    The FDA moved up the date of Monday's meeting following the May publication of a study by The New England Journal of Medicine that generated new concerns about Avandia's safety. The pooled analysis of 42 studies revealed a 43 percent higher risk of heart attack for those taking Avandia compared with people taking other diabetes drugs or no diabetes medication.

    About 1 million Americans with Type 2 diabetes use Avandia to control blood sugar by increasing the body's sensitivity to insulin. That sort of treatment has long been presumed to lessen the heart risks already associated with the disease, which is linked to obesity. News that Avandia might actually increase those risks would represent a "serious limitation" of the drug's benefit, according to the FDA.
    Copyright 2007 by The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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