FDA reviews Avandia safety data

ROCKVILLE, Md. The Food and Drug Administration is reviewing data from a large clinical study of a diabetes drug that some have said increases the risk of heart attacks in patients, the agency said Monday.

The FDA is reviewing the RECORD study, a trial of GlaxoSmithKline’s Type 2 diabetes treatment Avandia (rosiglitazone). The agency said the reviews are ongoing and that it has not made any new recommendations regarding the drug, but will present any new cardiovascular safety data at a public meeting in July. The FDA did not indicate that the announcement was related to a report by the Senate Committee on Finance and an article in The New York Times concerning Avandia.

GSK lashed out at the committee and the Times during the weekend over reports that the British drug maker knew of cardiovascular risks associated with the drug prior to the May 2007 publication of a study about them in the New England Journal of Medicine, saying they were based on unscientific premises.

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