FDA Seeks Strictest Warning for Diabetes Drugs

The request concerning Avandia and Actos was issued May 23 but not made public until Wednesday

By Steven Reinberg
HealthDay Reporter

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WEDNESDAY, June 6 (HealthDay News) -- The U.S. Food and Drug Administration has asked that two controversial type 2 diabetes drugs carry a "black box" warning on the potentially heightened risk of congestive heart failure in some patients.

In prepared testimony before a Congressional committee that was convened Wednesday following a published report on the cardiac dangers of Avandia, FDA Commissioner Dr. Andrew von Eschenbach said the agency had asked that Avandia, made by GlaxoSmithKline, and Actos, made by Takeda Pharmaceuticals, carry the more prominent warning because "despite existing warnings, these drugs were being prescribed to patients with significant heart failure."

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According to von Eschenbach's testimony, the request for the warning -- the strictest one possible -- was issued to both companies May 23, two days after publication of a study in the New England Journal of Medicine that found Avandia (rosiglitazone) increased the risk of heart attack by as much as 43 percent.

But the decision to request the heightened warning wasn't made public until von Eschenbach's appearance before the House Committee on Oversight and Government Reform, which is reviewing the FDA's role in the Avandia controversy.

The May 21 Avandia study was led by Dr. Steven Nissen, a Cleveland Clinic cardiologist who was among the first to warn about the heart risks posed by the now-banned arthritis drug Vioxx.

Following the release of the NEJM study on Avandia, the FDA issued a safety alert, but stopped short of asking for a stronger warning label, saying more analysis was needed.

"The Food and Drug Administration is aware of a potential safety issue related to rosiglitazone," Dr. Robert J. Meyer, director of FDA's Office of Drug Evaluation II, said during a May 21 teleconference. But, he added, "At this point, we have not reached a definitive conclusion on the data. We don't feel there is consistent enough data to make a decision from a regulatory standpoint. We are not ready to make an action."

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