FDA reports says Avandia can hurt heart: NY Times investigative report

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From a report in Yahoo News, which is the source for this posting  – FDA reports says Avandia can hurt heart: report:

According to a report by the NY Times yesterday, February 19, 2010, Confidential U.S. government reports recommend that GlaxoSmithKline Plc’s diabetes drug Avandia be pulled from the market because it can hurt the heart.

Two authors of the report, Dr. David Graham and Dr. Kate Gelperin of the FDA, both concluded that it should be removed from the market.

According to Yahoo News, Sales of Avandia, once Glaxo’s second biggest-selling product, plummeted two years ago after a U.S. study linked it to an increased risk of heart attack in a conclusion disputed by Glaxo.

According to the Times reporter, Gardiner Harris, an FDA advisory board voted, 8-7, in 2007 to accept the advice of an independent committee that while Avandia might increase the risk of heart attack, it should stay on the market.

A U.S. Senate investigation into the product “said Glaxo failed to warn patients earlier that Avandia was potentially deadly” – according to the Times report.

The Times said the internal FDA findings reflected a fierce debate inside the agency about Avandia. The newspaper quoted Glaxo as saying it had studied Avandia extensively and that “scientific evidence simply does not establish that Avandia increases” heart attack risk.

At the end of last year, Dr. Janet Woodcock, director of the FDA’s drug center, wrote an internal memorandum that “there are multiple conflicting opinions” about Avandia and ordered officials to assemble another advisory committee to reconsider if the drug should be sold.

The Times quoted FDA Commissioner Margaret Hamburg as saying on Friday, “I await the recommendations of the advisory committee.”

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