FDA scrutinizes Avandia’s safety risks ahead of meeting to decide fate of diabetes pill
By APFriday, July 9, 2010
FDA review spotlights heart risk of diabetes pill
WASHINGTON — A review by federal health scientists reinforces potential ties between the diabetes pill Avandia and heart attack and death, opening the door for government action, including a possible withdrawal of the once blockbuster drug.
The FDA posted an exhaustive 700-page review of the drug online ahead of a meeting next week to review the safety of Avandia, which is used by hundreds of thousands of diabetics in the U.S.
Prescriptions for the GlaxoSmithKline drug have plummeted since 2007, when a medical journal article first linked the drug to heart attacks. The FDA responded by adding a warning label to the drug.
But new data on Avandia’s risks and pressure from Capitol Hill have prompted the agency to re-examine the drug’s safety.
Tags: Diabetes, Diseases And Conditions, North America, United States, Washington
