GSK Updates Prescribing Information for Avandia

GlaxoSmithKline announced that the FDA has approved updated U.S. prescribing information for the thiazolidinediones (TZD) class of medicines used in the treatment of Type 2 diabetes.

According to GSK, the approval allows the company to implement changes in the label for Avandia (rosiglitazone maleate).

The label will contain a boxed warning, which increases the prominence of an existing warning for all medicines in the TZD class on the risk of congestive heart failure, the company said.

The boxed warning also will note that TZDs are not recommended in patients with symptomatic heart failure, and that initiation of TZDs in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated.

The changes related to congestive heart failure are being implemented on the labels of all rosiglitazone-containing products: Avandia, Avandamet  (rosiglitazone maleate and metformin hydrochloride) and Avandaryl  (rosiglitazone maleate and glimepiride).