FDA staffers disagree on safety of one-time blockbuster diabetes drug Avandia

By AP
Tuesday, July 13, 2010

Summary Box: Drug safety debate exposes FDA rift

DIABETES DEBATE: The Food and Drug Administration is asking a panel of outside physicians to weigh in on the safety of Avandia, a former blockbuster drug that some experts believe increases heart risks.

FDA DIVIDED: As the FDA began a two-day meeting Tuesday to discuss Avandia’s future, it became clear that the agency’s own scientists are deeply divided.

ONE STUDY, TWO VIEWS: FDA scientists gave conflicting reviews of a key study that drugmaker GlaxoSmithKline says proves its drug is safe.

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