The safety of Avandia (rosiglitazone) comes under U.S. government scrutiny starting Tuesday, as an advisory panel of experts begins two days of hearings.
The new information released by the Times comes after new doubts surfaced last week on a key trial that helped keep Avandia on the market.
Last Friday, a medical reviewer for the U.S. Food and Drug Administration posted remarks on the agency's Web site suggesting that GlaxoSmithKline's "mishandling" of trial results may have masked some cardiovascular effects of Avandia.
The official's posting was part of a safety reassessment package prepared for the FDA's advisory panel meeting.
At issue in the review posting were the results of the landmark RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes) trial, which was done by Glaxo at the FDA's request. The results, announced in June of 2009, found that Avandia raised the risk of heart failure but not to a level of statistical significance. The study also concluded that the drug did not increase the risk of cardiovascular disease or overall death.
In his posting, Thomas A. Marciniak, medical team leader of the division of cardiovascular and renal products at the FDA's Center for Drug Control and Evaluation, said that "RECORD was inadequately designed and conducted to provide any reassurance about the [cardiovascular] safety of rosiglitazone" and that "RECORD suggests the (sic) rosiglitazone increases the risk for [heart attacks]."
Last June, Glaxo used the trial results to tout the drug's safety.
"RECORD provides important and reassuring information about Avan
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