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Glaxo Avandia Recall Looms as FDA Questions Safety

GlaxoSmithKline Plc’s study of its once best-selling diabetes pill Avandia doesn’t prove the drug is safe, according to U.S. regulators considering whether to recall it amid doctors’ concerns it causes heart complications.

The study, called Record, “was inadequately designed and conducted to provide any reassurance about the cardiovascular safety” of the drug, said Thomas A. Marciniak, a medical team leader at the Food and Drug Administration, in an agency review of Avandia released today. “The results do confirm and extend the recognized concerns regarding increased heart failure and heart failure deaths.”