FDA Reviews Avandia Safety Data

Washington, DCThe US Food and Drug Administration (FDA) is reviewing data from a long-term study regarding Avandia. The study, nicknamed RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes), was designed to evaluate how safe rosiglitazone (Avandia) is for patients with type 2 diabetes mellitus.

The FDA warns that patients who are taking Avandia should be monitored for signs and symptoms of heart failure, including excessive and rapid weight gain, difficulty breathing and/or swelling. "This work is ongoing and no new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time," the agency announced.

Following review of the RECORD study, the FDA will present all existing cardiovascular safety data regarding rosiglitazone to a joint public meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. That meeting is expected to take place in July 2010.

A recently released US Senate report alleges that GlaxoSmithKline, the manufacturer of Avandia, knew about the risks associated with the drug but failed to warn the public in a timely manner.

According to Bloomberg on 2/24/10, GlaxoSmithKline called the report inaccurate, incomplete and full of "errors of fact, omission and inference."

Patients who are currently taking Avandia should discuss any questions or concerns they have with their doctors.