FDA Panel Recommends Avandia Remain on Market

But panel also votes for serious label revisions or restrictions on sales
By Beth Gilbert
HealthDay Reporter

THURSDAY, July 15 (HealthDay News) -- After two days of deliberations, sparked by concerns over cardiovascular safety issues, a U.S. Food and Drug Administration advisory panel, comprising 33 experts, has recommended that rosiglitazone (Avandia) remain on the market with tightened controls or restricted sales.

In the final vote, 12 panelists voted to withdraw rosiglitazone from the market, 10 voted to keep the drug on the market with serious label revisions and possible restrictions on sales, seven voted to add further warnings to the drug's label, and three voted to keep the drug on the market with no change to the drug's current status; one panelist abstained from the vote.

In addition, the majority of the panel voted to continue with the Thiazolidinedione Intervention With Vitamin D Evaluation trial, which aims to evaluate the cardiovascular effects of long-term treatment with rosiglitazone, pioglitazone (Actos), or placebo when added to standard care in patients with type 2 diabetes and a history of -- or at risk for -- cardiovascular disease. Effects of long-term vitamin D supplementation on cancer and mortality will also be assessed in the trial.

"The advisory committee's deliberations were difficult, since the available data were limited, controversial, and subject to multiple interpretations by seasoned investigators and reviewers," Ralph Sacco, M.D., president of the American Heart Association, said in a statement. "We agree with the committee that further research is necessary to answer the remaining questions, and we encourage the FDA to continue to evaluate and assess carefully all new clinical data as they become available."

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