Despite recent studies suggesting the type-2 diabetes drug Avandia (rosiglitazone) may cause serious cardiovascular problems, a U.S. Food and Drug Administration advisory panel voted 22 to one for the medication to remain on the shelves.
In July, researchers from Wake Forest University School of Medicine in Winston-Salem, N.C., report thiazolidinediones, a class of drugs that includes Avandia and Actos (pioglitazone), may double the risk of heart failure. Study authors report that over a 26-month period, for every 50 type-2 diabetes patients taking one of the thiazolidinediones, one additional patient would develop heart failure.
Earlier this year, an article published in The New England Journal of Medicine revealed a link between Avandia and increased risk of heart attacks. “In view of the potential cardiovascular risks and in the absence of evidence of other health advantages, except for laboratory measure of glycemic control, the rationale for prescribing rosiglitazone at this time is unclear,” wrote Bruce Psaty, M.D., Ph.D., and Curt Furberg, M.D., Ph.D., in the May 2007 article.
The FDA advisory panel met earlier this week to consider this, and other research, before making the recommendation to the Agency, which is not required to follow the recommendation, though it usually has in the past.
The panel agreed there is evidence that Avandia does increase the risk of heart attacks, and the makers of the drug will likely need to place new warnings on the packaging.
SOURCE: Diabetes Care, 2007:30:2148-2153; Ivanhoe interview with Bruce M. Psaty, M.D., Ph.D.; The New England Journal of Medicine, published online May 21, 2007