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Health Canada reviewing stop-smoking drug Champix (varenicline tartrate) and potential risk of heart problems in patients with heart disease

Starting date:
June 27, 2011
Posting date:
June 27, 2011
Type of communication:
Information Update
Source of recall:
Health Canada
Product Safety
General Public
Identification number:

Health Canada is informing Canadians of an ongoing review of the smoking-cessation aid Champix (the brand name for the prescription drug varenicline tartrate) and the possibility of a slightly increased risk of heart-related side effects in patients who have cardiovascular disease.

The U.S. Food and Drug Administration recently communicated its findings from a review of new data from a clinical trial involving 700 smokers with cardiovascular disease. Cardiovascular disease is a broad term covering any disease that affects the heart and/or blood vessels. The risk for patients with cardiovascular disease taking Champix was found to be 2%, compared to 1% for those taking no drug.

Health Canada is evaluating this and all other available information. We will take appropriate action as necessary based on the results of our review. Canadians will be updated with any new safety recommendations regarding Champix use.

Champix is considered an effective smoking-cessation aid when used as part of a support program. Smoking by itself is a major known risk factor for cardiovascular disease and heart-related events.

Heart-related side effects have occurred rarely in clinical trials for Champix. Reports have included chest pain, irregular heartbeat, heart attack and stroke. This information is included in the current prescribing information for Champix.

Patients who have questions or concerns about their Champix therapy should speak to their healthcare professional.

How to report side effects to health products

To report a 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 and send it to us using one of these methods:

  • Fax: 1-866-678-6789
  • Internet: MedEffect Canada
  • Mail: Canada Vigilance Program
    Marketed Health Products Directorate
    Ottawa, ON, Address Locator 0701E
    K1A 0K9

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For more information

Health Canada reminds consumers who are thinking of quitting smoking to talk with a health care professional about the specific risks and benefits of all smoking cessation options to help determine the most appropriate method for them. Information and resources are also available: