Issue Date: June 11, 2007
Warnings issued on diabetes drugs
On June 6, FDA revealed it has issued strict warnings of heart risks on two type 2 diabetes drugs, Avandia and Actos, which are in the same therapeutic class. At a May 23 hearing of the House Committee on Oversight & Government Reform, FDA Commissioner Andrew C. von Eschenbach said he had asked the manufacturers of the drugs to place the most prominent type of warning on the labels, a "black box warning." But the request was not made public until the hearing. Von Eschenbach stressed that studies on the association between Avandia (rosiglitazone maleate) and heart risks are inconsistent and that the dangers did not become clear until recently. A comprehensive reanalysis of the data performed at FDA this year and a study published on May 21 in the New England Journal of Medicine confirmed the possibility that Avandia may pose excess risks, he said. However, Rep. Henry A. Waxman (D-Calif.) said FDA was remiss in not requiring the drug's manufacturer GlaxoSmithKline "to conduct a thorough postmarket study of Avandia's heart risks."
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