An advisory panel to the U.S. Food and Drug Administration has voted that the Type 2 diabetes drug rosiglitazone (brand name Avandia; also found in Avandamet and Avandaryl) should remain on the market. The panel does, however, recommend that the drug carry new safety warnings to reflect its risk to the heart.
The panel, which was convened to address the recent controversy over the safety of rosiglitazone, met on Monday, July 30. It heard testimony from various speakers: Some argued that risks associated with rosiglitazone outweighed the drug’s benefits, while others denied that the drug posed a greater risk of heart attack than other diabetes drugs. Subsequently, the panel members voted 20 to 3 that the drug does pose a risk to heart health according to available research data, but also voted 22 to 1 to keep rosiglitazone on the market because that data are not conclusive.
Rosiglitazone made headlines in May when an analysis of multiple studies, published in The New England Journal of Medicine, linked taking the drug to an increased risk of heart attack. (See “Type 2 Drug Avandia Linked to Increased Risk of Heart Attacks.”) Since then, data from other studies supplied by both independent researchers and drug manufacturer GlaxoSmithKline has come to light, some of it showing increased risk and some showing no evidence of excess risk.
The advisory panel suggested that the FDA require rosiglitazone to carry stricter warning labels and that it not be prescribed to certain high-risk groups. For instance, statistical analysis by the FDA has shown that people who use rosiglitazone along with insulin have a significantly elevated risk of heart attack. People who already have heart disease, additionally, should not be prescribed rosiglitazone. And people who have congestive heart failure should also not be prescribed rosiglitazone (or pioglitazone [Actos], the other drug in the thiazolidinedione class), which can make the chronic condition worse. The FDA recently asked both drugs to carry “black box” warnings, the strongest warning the FDA requires, about this risk.
However, the panel did not feel that evidence about rosiglitazone’s risks was strong enough to require that the drug be pulled from the market. One expert stated that the FDA should call for a study dedicated to reviewing heart risks associated with rosiglitazone.
While the FDA is not required to follow the recommendations of its advisory panels, it usually does so.
This blog entry is part of DiabetesSelfManagement.com’s continuing coverage of the rosiglitazone controversy. For more background information, please see the following recent entries: