Health Canada

Health Canada

July 21, 2011 11:19 ET

Multaq: Health Canada Reviewing Heart-Related Risk

OTTAWA, ONTARIO--(Marketwire - July 21, 2011) - Health Canada is reviewing the heart-related safety of the prescription drug Multaq (the brand name for dronedarone). Multaq is used to reduce the risk of hospitalisation due to "atrial fibrillation," which is an abnormal heart rhythm.

Health Canada is aware of the Sanofi company's decision (http://en.sanofi.com/binaries/20110707_PALLAS_en_tcm28-33021.pdf) to stop the PALLAS (Permanent Atrial fibriLLAtion outcome Study using Dronedarone on top of standard therapy) Phase IIIb clinical trial. The study was stopped because of a higher number of severe cardiovascular-related adverse events in patients taking Multaq relative to patients not taking Multaq.

The PALLAS study was investigating the use of Multaq in patients over 65 years of age with permanent atrial fibrillation in addition to other forms of heart disease. Permanent atrial fibrillation in this trial is atrial fibrillation that has not responded to any form of medical therapy for at least 6 months. In Canada, Multaq is authorized only for the treatment of patients with a history of, or who currently have various forms of intermittent atrial fibrillation ("non-permanent atrial fibrillation").

Health Canada is currently evaluating the available information with respect to Multaq and the potential for an increased risk of cardiovascular events. Cardiovascular events are problems involving the heart and circulatory system, such as heart attack and stroke. Health Canada will take appropriate regulatory action as necessary once the review is complete. This could include updating the labelling information with new safety information. Health Canada will keep health professionals and the public informed of new safety recommendations coming out of the review as appropriate.

Canadians are reminded that Sanofi, working with Health Canada, communicated to health professionals (http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2011/multaq_hpc-cps-eng.php) and the public (http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2011/multaq_pc-cp-eng.php) in March 2011 on Multaq and the risk of liver injury.

Patients with questions or concerns about Multaq should talk to their health professional.
The current labelling for Multaq, which contains important prescribing and safety information for health professionals and patients, is available by searching Health Canada's Drug Product Database (http://webprod3.hc-sc.gc.ca/dpd-bdpp/index-eng.jsp).

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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