After two days of hearings, an advisory committee to the U.S. Food and Drug Administration (FDA) recommended that the FDA allow the type 2 diabetes drug rosiglitazone (brand name, Avandia), to stay on the market, but with most committee members suggesting that the label be revised to include increased warnings. Rosiglitazone is one in a class of drugs called thiazolidinediones (TZDs), used to treat type 2 diabetes.
The advisory committee voted 20 to 12 (with one abstention) to keep rosiglitazone on the market and recommended 20 to 10 (with two abstentions) that the TIDE trial continue. This trial, requested by the FDA, is evaluating patients with type 2 diabetes and a history of or risk for cardiovascular disease, and comparing the cardiovascular effects of long-term treatment with rosiglitazone, pioglitazone or placebo when added to standard care. The trial will also compare the effects of long-term supplementation with vitamin D on death and cancer.
The FDA will consider these recommendations and make a final ruling. "The advisory committee's deliberations were difficult, since the available data were limited, controversial, and subject to multiple interpretations by seasoned investigators and reviewers," said Ralph Sacco, M.D., president of the American Heart Association. "We agree with the committee that further research is necessary to answer the remaining questions, and we encourage the FDA to continue to evaluate and assess carefully all new clinical data as they become available."
For patients with diabetes, the most serious consequences are heart disease and stroke, and the risk of suffering from them is significantly increased when diabetes is present.
"It's especially important that patients not change or stop medications without consulting their healthcare provider," said Sacco.
For patients with diabetes, the American Heart Association recommends the following: