Health Canada: Status of Rosiglitazone Drugs [Avandia, Avandamet, and Avandaryl] in Canada

July 15, 2010 – In the light of recently published scientific studies and an upcoming U.S. Food and Drug Administration (FDA) Advisory Committee meeting examining the heart-related (cardiovascular) safety of the diabetes drug rosiglitazone, Health Canada is informing health care professionals and Canadians of the current status of this drug in Canada. Rosiglitazone is authorised for use in the treatment of type 2 diabetes. In Canada, three prescription drugs are currently available that contain rosiglitazone: Avandia [contains Rosiglitazone only], Avandamet [contains Rosiglitazone and Metformin], and Avandaryl [contains Rosiglitazone and Glimepiride].

Heart-related events have previously been identified and included in the Canadian Product Monographs for rosiglitazone drugs. In 2007, Health Canada conducted a review of heart-related safety information for rosiglitazone. As a result, the Canadian Product Monographs for Avandia, Avandamet and Avandaryl were updated to include important new restrictions for use. These new restrictions were communicated to the public and to health care professionals in November 2007.

It is important to note that the indications for use for rosiglitazone drugs are more restrictive in Canada than in the United States.

In Canada:

• Rosiglitazone is not approved for use alone (i.e., as a “monotherapy”), unless metformin (another diabetes drug) treatment is inappropriate.

• Rosiglitazone is not recommended for use as part of a “triple therapy” (i.e., in combination with the diabetes drugs metformin and sulfonylurea).

• Rosiglitazone is not to be used (i.e., it is contraindicated) in patients with any stage of heart failure.

Health Canada would like to remind health professionals that, when prescribing rosiglitazone, they should follow the prescribing information in the Canadian Product Monograph. In addition to the restrictions listed above, health professionals are reminded that rosiglitazone is not recommended for use with insulin. Patients with questions or concerns about Avandia, Avandamet, or Avandaryl should talk to their physician or pharmacist.

Health Canada’s review of rosiglitazone safety is ongoing. Rosiglitazone drugs have been the subject of several post-marketing studies that have continued to provide information about the risk of heart-related events. Market Authorization Holders (i.e., companies) are responsible for their marketed therapeutic health products and for continuous assessment of their benefits and risks. As the federal regulator, Health Canada is taking these studies, including their strengths and limitations, into account as we continue to monitor rosiglitazone safety.

No new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time. The benefits of rosiglitazone are still considered to outweigh the risks when used as directed in the Canadian Product Monographs and following the advice contained in the public and health care professional communications issued in November 2007.

Health Canada continues to review new scientific evidence as it emerges and will monitor the upcoming U.S. FDA Advisory Committee proceedings on July 13 and 14. Health Canada will take the appropriate regulatory action necessary, including informing health care professionals and Canadians as appropriate.

Product Monographs are available by search of Health Canada’s online Drug Product Database.