An unpublished study has linked GlaxoSmithKline’s diabetes drug Avandia to 48,000 incidents of heart attacks, strokes, and other adverse medical issues in Medicare patients between 1999 and 2009. The study was conducted by an FDA scientist and comes about a month before an FDA panel is set to review the safety concerns of the diabetes drug Avandia.
Dr. David Graham, the FDA scientist who conducted the study, is an outspoken critic of Avandia and has called for its withdrawal from the marketplace due to its safety concerns and its link to an increased risk of heart attacks and strokes in diabetic patients.
According to an article in the Wall St. Journal, the study found that “patients taking Avandia had a 27% greater chance of suffering a stroke, a 25% increased risk of suffering heart failure and a 13% greater chance of dying. Avandia increased the overall risk of experiencing heart attack, stroke, heart failure or death by 17%, the study said.”