FDA reviews TZD safety

FDA reviews TZD safety

Thiazolidinediones (TZDs) have been under intense scrutiny in recent years after rosiglitazone (Avandia^®) was linked to increased cardiovascular morbidity and mortality in several studies. In recent weeks, The New York Times has reported that some FDA staffers are recommending that rosiglitazone be removed from the market. According to the story in the Times, a "confidential government report" states that about 500 heart attacks and 300 cases of heart failure per month could be averted if patients were switched from rosiglitazone to pioglitazone (Actos^®). Congress has even gotten involved, specifically the Senate's Committee on Finance, which in January issued a 350-page report on rosiglitazone, focusing on GlaxoSmithKline's handling of evidence of possible cardiac risks associated with use of the drug. Now the American Heart Association and the American College of Cardiology have weighed in on the issue suggesting there is insufficient evidence to support the use of pioglitazone over rosiglitazone and that both drugs increase the risk for heart failure and should not be initiated in patients with class III/IV heart failure. They further state that the drugs should not be used with an expectation of benefit with respect to ischemic heart disease events (Circulation, published on-line Feb. 23, 2010). Meanwhile, the FDA web site reports that the Agency is reviewing data on rosiglitazone and is planning a public meeting in July 2010 to present all known heart-related safety data on the drug and provide an updated assessment of the risks and benefits of rosiglitazone and the treatment of type 2 diabetes.