FDA Drug Safety Communication

FDA is notifying the public that information on the cardiovascular risks (including heart attack) of the diabetes drug rosiglitazone has been added to the physician labeling and patient Medication Guide. This information was first announced by FDA on September 23, 2010 as part of new restrictions for prescribing and use of this drug.

Rosiglitazone is sold as a single-ingredient product under the brand name Avandia. Rosiglitazone is also sold as a combination product under the brand name Avandamet (contains rosiglitazone and metformin) and under the brand name Avandaryl (contains rosiglitazone and glimepiride).

In addition to describing the cardiovascular risks, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:

- In patients already being treated with these medicines

- In patients whose blood sugar cannot be controlled with other antidiabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).

At this time, FDA has only approved these safety-related changes to the physician labeling and Medication Guides for the rosiglitazone-containing medicines. The Risk Evaluation and Mitigation Strategy (REMS), which will restrict rosiglitazone-containing medicines' availability, has not yet been approved and formally implemented.

FDA will be providing further information on this REMS program in the coming months. FDA expects to approve the REMS by Spring 2011, and for the manufacturer to complete implementation 6 months thereafter.

View the full FDA Drug Safety Communication on FDA.gov