Labeling Revised for Diabetes Drug Avandia
On Nov. 14, 2007, FDA announced that the manufacturer of Avandia (rosiglitazone) has agreed to add new information about potential increased risk for heart attacks to the existing boxed warning. This action follows recommendations made at the July 2007 joint meeting between FDA's Endocrine and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. Avandia, which is used to treat type 2 diabetes, is manufactured by GlaxoSmithKline (GSK), Philadelphia, Pa.
Why the New Labeling?
After carefully reviewing several sources of study data, FDA concluded there is not enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. Because available data are inconclusive—studies have neither confirmed nor excluded the risk—FDA is allowing Avandia to stay on the market while a new long-term study to evaluate the potential cardiovascular risk of Avandia, compared to an active control agent, is conducted by GSK. The company agreed to add new information to the drug's labeling, warning of the potential for increased risk of heart attacks.
People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk with their health care provider about the revised warning as they evaluate treatment options. FDA advises health care providers to closely monitor patients who take Avandia for cardiovascular risks.
This article appears on FDA's Consumer Update page, which features the latest on all FDA-regulated products.
Date Posted: November 15, 2007