Rosiglitazone (Avandia) Deleted from VA Formulary for Diabetes

10/30/2007- The U.S. Department of Veterans Affairs has deleted rosiglitazone (Avandia), the diabetes drug that has been linked to increased risk of myocardial infarction and heart failure, from its formulary.

The action followed an internal review of medical records of diabetes patients treated in the VA system. Moreover, the VA representative to the FDA's 15-member Drug Safety Oversight Board (DSOB) rallied other members in an attempt to have rosiglitazone pulled from the market.

According to Senator Chuck Grassley (R-Iowa), the move to ban rosiglitazone fell only one vote short. Grassley said the DSOB met on Oct. 2 and seven members of the DSOB voted to pull the drug.

In a letter to FDA Commissioner Andrew C. von Eschenbach, M.D., Grassley demanded that the FDA make public both the DSOB vote and "information from the FDA regarding the internal policies and procedures governing the DSOB and the terms and conditions governing release of information from the DSOB to the public."

In July members of two FDA advisory boards, meeting jointly, voted 22 to one to keep the drug on the market. But those same advisers also overwhelmingly agreed that the drug should carry a black box warning about ischemic heart disease. The drug already has a black box warning for heart failure.

The FDA is expected to announce rosiglitazone label changes within the next few weeks and although the agency is not required to follow the advice of its advisers, it is widely expected that the agency will order a black box warning about ischemic heart disease.

In his letter, dated Oct. 26, Grassley said he has been investigating the FDA's handling of rosiglitazone since May when the New England Journal of Medicine published a meta-analysis that reported a 43% increase in the relative risk of MI and a 64% increase in relative risk of cardiovascular deaths.

Rosiglitazone is marketed by GlaxoSmithKline.