FDA panel to examine health risks from diabetes drugs

6/24/2008

NEW YORK The Food and Drug Administration will consult with a group of advisers next week about studies of health risks for drugs that treat Type 2 diabetes, the FDA announced Monday.

The panel of advisers, from outside the regulatory agency, will meet July 1 and 2 in Silver Spring, Md. There, the FDA will ask it to determine what studies should be conducted to assess the risks that diabetes drugs post to heart health and whether those studies should happen before or after the drugs have received approval.

Last year, the FDA announced that labels for GlaxoSmithKline’s Avandia and Takeda Pharmaceutical’s Actos should have the strongest warnings because they could increase the risk of heart failure, even though both drugs had been on the market for about eight years.

Avandia, GSK’s second largest product, had sales of $2.4 billion in 2007, according to GSK financial data.

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