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FRIDAY, July 9 (HealthDay News) -- With a crucial recommendation on the fate of the controversial diabetes drug Avandia due next week, U.S. health officials seem to be gearing up for tough scrutiny over the drug's future.
A U.S. Food and Drug Administration (FDA) advisory committee will be meeting next Tuesday and Wednesday to pore over numerous studies on the drug's safety that have accumulated over the past three years, since doubts about its safety first arose.
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At stake is whether Avandia will continue to be marketed in the United States.
The advisory committee's options "range from allowing the continued marketing of Avandia and revising the label to remove the boxed warning, all the way to withdrawal from the U.S. market," explained Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, at a packed news briefing late Thursday. "We're asking them to pick one, vote on it and explain the rationale."
In a similar move, meanwhile, the European Medicines Agency announced Friday morning that it would also review Avandia's safety. The Associated Press reports that the review will be conducted by the agency's Committee for Medicinal Products for Human Use from July 19 to July 22. Depending on the outcome, marketing authorization for the drug in Europe could be revoked or changed.
Avandia (rosiglitazone) is one of two blood-sugar-lowering drugs in the class of medications known as thiazolidinediones (TZDs). The other drug is Actos (pioglitazone), which so far has not raised safety red flags. Both are used by type 2 diabetics.
The first drug in the class, Rezulin (troglitazone), was withdrawn from the market in the late 1990s after reports of liver toxicity, Woodcock noted.
Both Avandia and Actos came with warnings regarding heart failure when they were first approved, though not ischemic (involving restricted blood flow) heart trouble.
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