FDA Advisory Group Says Avandia^® is Safe

The FDA Advisory Group advised that the diabetes drug Avandia^® should remain on the U.S. market even though data from other sources suggests it may raise the risk of heart attack among some patients.

The Food and Drug Administration will consider the recommendation from outside experts but usually follows the advisory group’s advice.

The American Diabetes Association continues to urge "patients taking this medication to consult with their physician as to its benefits and risks. The ADA also reminds patients, however, that they should not stop taking any prescribed medications without first discussing the issue with their health care provider."

Background

The New England Journal of Medicine published an article, which suggested that Avandia increased the risk of heart death and heart attacks among patients with type 2 diabetes.

The findings were based on analysis of published data from clinical trials that compared the risk of heart attack and heart disease-related death in patients on Avandia with patients who took a placebo or other diabetes drugs. Forty-two clinical trials were analyzed, which involved nearly 28,000 patients. The results showed that more than 65 percent of the deaths among diabetic patients in the trials of the drug could be attributed to heart disease. Heart disease is a common complication of diabetes but the possibility that Avandia could increase this risk warrants an alert to TRICARE beneficiaries.