FDA announces cardiovascular risks added to rosiglitazone (Avandia) labels

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The FDA announced on 3 February 2011 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.

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 and in patients whose blood sugar cannot be controlled with other anti-diabetic 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.

 

On 23 September 2010 the FDA announced that it would significantly restrict the use of rosiglitazone-containing medicines to patients with Type 2 diabetes who cannot control their blood sugar on other medicines. These new restrictions were in response to data that suggested an elevated risk of heart attacks in patients treated with rosiglitazone.