Avandia hearing

By United Press International   |   July 13, 2010 at 8:48 AM   |   0 comments

GAITHERSBURG, Md., July 13 (UPI) -- U.S. regulators open hearings Tuesday in suburban Washington to consider evidence regarding the diabetes drug Avandia and its alleged link to heart disease.

Avandia manufacturer GlaxoSmithKline claims clinical trials have shown the drug to be safe but others have suggested a possible link between Avandia and an increased risk of heart-related problems.

GlaxoSmithKline pointed to a study called RECORD as support for its stated safety of Avandia. However, that study was questioned by the U.S. Food and Drug Administration in documents released last week ahead of the panel's convening Tuesday and Wednesday. An FDA memo said the study was "inadequately designed."

The National Institutes of Health states rosiglitazone, which has been marketed as Avandia since 1999, is prescribed as part of a treatment regimen for type 2 diabetes. The drug increases the body's sensitivity to insulin, NIH says.

Sales of the drug totaled about $3 billion in 2006 prior to a New England Journal of Medicine study that indicated a higher risk of heart problems among people taking Avandia. Sales in 2009 were about $1.2 billion.

The FDA is expected to issue a determination on whether to order Avandia pulled from the market late this week.

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