In a remarkable climax to a long-running drama, the FDA today lifted major restrictions on rosiglitazone (Avandia, GlaxoSmithKline). The drug has been the subject of intense criticism and controversy since the 2007 publication of the famous Nissen meta-analsysis that first raised the possibility that the blockbuster diabetes drug might increase the risk of heart attack and cardiovascular death.
The FDA said its actions were “consistent with the recommendations of expert advisory committees.” In June of this year an FDA panel reviewed re-adjudicated data from the RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes) trial and concluded that the trial had not found an elevated risk of heart attack or death associated with rosiglitazone.
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