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The FDA conducted its own analysis of the risks of heart attack and other heart problems associated with the Type 2 diabetes drug Avandia, and had found significantly increased risks long before the present controversy over Avandia erupted May 21 with the publication of a meta-analysis in The New England Journal of Medicine (NEJM). The NEJM report described a 40 percent higher risk of heart attack and heart-related deaths among Avandia users compared to diabetics treated with other drugs or a placebo.
Confirming that the FDA has known of Avandia's risks for quite some time now, Senator Charles Grassley (R-Iowa) said in a floor statement in the Senate record that safety watchdogs within the FDA recommended "several months ago" that a black box (the strongest possible warning) be put on Avandia's label, although this action was never taken.
Avandia's Maker and the FDA Had the Data
The maker of Avandia, GlaxoSmithKline, supplied its own meta-analysis of post-marketing Avandia studies to the FDA about a year ago. The Glaxo analysis indicated a 31 percent increase in heart problems.
The FDA has been the focus of increasing criticism regarding Avandia since the NEJM report. Sen. Grassley said of FDA officials' contention that the agency must wait for the results of an ongoing Avandia study before taking further action, "That's a long time from now when you have millions of Americans taking this drug…Those numbers seem like a high enough threshold to me for the FDA to warn the American people of the possibility of a problem."
Rep. John Dingell (D-Mich.), chairman of the House Energy and Commerce Committee, said earlier this week that the FDA's handling of questions about Avandia seem to reflect dangerous shortcomings in the way it monitors safety, and that such questions would be taken up in the Committee’s efforts to force the FDA to be a tougher regulator.
“We learned from an FDA briefing that the agency has known about this problem for at least eight months and perhaps even longer,” Mr. Dingell said. “What we don’t know is why diabetics and their doctors haven’t been notified of the substantial risk to the heart from a drug prescribed to protect the cardiovascular system.”
(Sources: Washington Post and New York Times)
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