FDA Discredits Avandia Safety Study

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Dr. Thomas Marciniak, a reviewer for the U.S. Food and Drug Administration, has sharply critiqued GlaxoSmithKline's clinical trial of Avandia, GlaxoSmithKline's popular diabetes drug. The study flatly ignored 12 instances of heart problems among the participants. Studies have demonstrated that Avandia also increases the risk of fractures, swelling, heart attacks, strokes, and death. One patient in the study suffered a brain bleed, but the records of this complication were reportedly deleted. Another patient spent nine weeks in the hospital for a stroke, but that patient's records apparently did not reflect the catastrophic event.

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Published In: Administrative Agency Updates, Consumer Protection Updates, Health Updates, Products Liability Updates

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