The FDA's David GrahamÂ says that GSK's Avandia should be pulled from the market due to safety concerns. The safety expert made a presentation at today's committee hearing on the therapy that outlines the cardiovascular risks associated with Avandia while noting that the rival diabetes drug Actos does not raise risks. He topped that off by observing that Avandia has no unique short-term benefits and no demonstrated long-term benefits. It remains to be seen if another blow can knock Avandia out of the market--or if FDA officials will listen to what Graham has to say. Any new regulatory move against Avandia would be a big blow to Glaxo, which has seen the market for its blockbuster therapy wither as new reports come out illustrating health risks linked to the therapy.
- here's the article from The New York Times
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Researchers raise new warnings about Avandia. Report
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