Rosiglitazone label and medication guide updated with cardiovascular risks

FDA has announced that the physician labeling and patient medication guide for rosiglitazone (Avandia, GlaxoSmithKline) have been changed to include information on cardiovascular risks (including death) of this agent.

In addition, labeling has been revised to state that rosiglitazone and rosiglitazone-containing medications should only be used in patients already being treated with these agents, or in patients whose serum glucose levels cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare provider, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact). Rosiglitazone is also sold as a combination product under the brand name Avandamet (rosiglitazone and metformin) and under the brand name Avandaryl (rosiglitazone and glimepiride).

In late September 2010, FDA announced that it would significantly restrict the use of rosiglitazone-containing medicines to patients with type 2 diabetes who cannot control their serum glucose levels with other medications. These new restrictions came about as a 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 the manufacturer to complete implementation 6 months thereafter.