Health Canada

Health Canada

June 17, 2011 10:42 ET

Health Canada Reviewing Diabetes Drug Pioglitazone (Actos) and Potential Risk of Bladder Cancer

OTTAWA, ONTARIO--(Marketwire - June 17, 2011) - In light of studies suggesting an increased risk of bladder cancer with the diabetes drug pioglitazone, as well as actions taken by other regulatory agencies, Health Canada is informing healthcare professionals and Canadians that it is undertaking a review of the drug's status.

Pioglitazone is sold in Canada under the brand name "Actos" in addition to generic forms of the drug. It is used by itself or in combination with other diabetes drugs to control blood sugar levels in diabetic patients, when diet and exercise have failed.

Post-marketing reports of bladder cancer have been reported very rarely with the use of pioglitazone. This information is included in the Canadian Product Monograph. Health Canada has been closely monitoring this potential risk, and has been reviewing all relevant studies on an ongoing basis. We are taking these studies, including their strengths and limitations, into account as we continue to monitor pioglitazone safety.

Should the on-going review identify new safety information, Health Canada will take appropriate action as necessary. This can include updating Canadians with new recommendations regarding pioglitazone and the potential risk of bladder cancer.

The benefits of pioglitazone are considered to outweigh the risks when used as directed in the Canadian Product Monograph. Patients with questions or concerns about their diabetes treatment should talk to their physician or pharmacist.

Product Monographs are available by search of Health Canada's online Drug Product Database (http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/index-eng.php). Product Monographs provide detailed prescribing and safety information on a drug. Part III of the Product Monograph provides information specifically for consumers.

How to report side effects to health products

To report suspected adverse reaction to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) and send to us using one of these methods:

  • Fax: 1-866-678-6789
  • Internet: www.healthcanada.gc.ca/medeffect
  • Mail: Canada Vigilance Program
    Marketed Health Products Directorate
    Ottawa, ON, Address Locator 0701E
    K1A 0K9

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