GlaxoSmithKline said this week that a Senate report criticizing its handling of heart risks with its diabetes drug Avandia “mischaracterizes and distorts” the company’s record. As reported by the Associated Press, Glaxo is unhappy with the way the company’s response to reports of heart attacks caused by Avandia have been characterized by the Food and Drug Administration and the Senate Finance Committee. The Senate report, issued over the weekend, charged that Glaxo downplayed the drug’s safety risks and withheld important data from the FDA. “That suggestion is fundamentally flawed and contradicted by the record of extensive, ongoing interactions between GSK and the FDA,” states the company.
A report in May 2007 showed that Avandia users had a 43% higher risk of heart attacks than patients taking other diabetes drugs or no diabetes drugs at all.