FDA Spells Out Who Can Use Rosiglitazone

The US Food and Drug Administration (FDA) is notifying healthcare professionals and patients that information on the cardiovascular risks (including myocardial infarction) of rosiglitazone (Avandia) 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. 

• 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 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).

On September 23, 2010, the FDA notified healthcare professionals and patients that it would significantly restrict the use of rosiglitazone to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as myocardial infarction and stroke, in patients treated with rosiglitazone.

The FDA will require that GSK develop a restricted access program for rosiglitazone under a risk evaluation and mitigation strategy (REMS). Under the REMS, rosiglitazone will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take pioglitazone (Actos). Current users of rosiglitazone who are benefiting from the drug will be able to continue using the medication if they choose to do so.

Doctors will have to attest to and document their patients' eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug, and acknowledge they understand the risks. The agency anticipates that the REMS will limit use of rosiglitazone significantly.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.