Rosiglitazone labels update cardiovascular risks

February 22, 2011

FDA has announced that labeling for rosiglitazone (Avandia) has been changed to include information on cardiovascular risks (including death) connected with use of this agent.

FDA has announced that labeling for rosiglitazone (Avandia, GlaxoSmithKline) has been changed to include information on cardiovascular risks (including death) connected with use of this agent. In addition, labeling has been revised to state that rosiglitazone and medications that contain rosiglitazone should be used by patients already being treated with these agents, or by patients whose serum glucose levels cannot be controlled with other antidiabetic medications and who, after consulting with their healthcare providers, do not wish to use pioglitazone-containing medications (Actos, Actoplus Met, Actoplus Met XR, or Duetact).

Rosiglitazone is also sold as a combination product under the brand name Avandamet (containing rosiglitazone and metformin) and under the brand name Avandaryl (containing rosiglitazone and glimepiride).

In late September 2010, FDA announced that it would significantly restrict the use of medications containing rosiglitazone to patients with type 2 diabetes who cannot control their serum glucose levels with other medications. These new restrictions came about in response to data that suggested an elevated risk of myocardial infarction in patients treated with rosiglitazone.

The Risk Evaluation and Mitigation Strategy (REMS) that will restrict the availability of medications containing rosiglitazone has not yet been approved or formally implemented. FDA expects to approve the REMS by spring 2011 and expects the manufacturer to complete implementation 6 months thereafter.