Health Canada

Health Canada

January 19, 2012 12:59 ET

Champix: Updated Safety Information for the Smoking-Cessation Drug

OTTAWA, ONTARIO--(Marketwire - Jan. 19, 2012) - Health Canada is informing Canadians that our review of Champix (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_84-eng.php) is now complete and the label has been updated with new information with respect to cardiovascular safety. Champix (the brand name for varenicline tartrate) is a prescription drug used to help patients quit smoking in combination with supportive counselling.

Health Canada evaluated data from a quit-smoking clinical trial involving 700 smokers with cardiovascular disease (approximately 350 who received Champix and 350 who received a placebo or "sugar pills"). Cardiovascular disease is a broad term for any condition that affects the heart and/or blood vessels, including heart attack and stroke.

Although a slightly increased number of patients experienced serious heart-related events in the group treated with Champix compared to the group treated with placebo, the study was not adequately designed to be able to test the cardiovascular safety of Champix. The small study size combined with other study design weaknesses make it impossible to draw conclusions based on these data. The possibility of an increased risk of heart attack or stroke in patients with cardiovascular disease can neither be confirmed nor ruled out at this time.

The drug labelling for Champix has been updated to include a more detailed description of the study and findings, along with precautions for patients with respect to cardiovascular safety.

Patients are advised to seek immediate medical attention if they think they might be experiencing a heart attack or stroke. Symptoms of a heart attack include chest pain; pain in the arms, back, neck, jaw or stomach; shortness of breath; sweating; and nausea. Symptoms of stroke include suddenly feeling weak or numb in the face, arms or legs; trouble speaking; vision problems; sudden severe headache; and dizziness.

It is important to note that smoking by itself is a major known risk factor for cardiovascular disease and that patients with cardiovascular disease can benefit greatly from quitting smoking. Patients with questions or concerns about Champix should talk to their health professional.

Health Canada will continue to evaluate new data on the cardiovascular safety of Champix as it becomes available. Should new safety information be identified, Health Canada will take appropriate action and inform Canadians as necessary.

Drug labels, or "Product Monographs," contain important prescribing and safety information for health professionals and patients, and are available by search of 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 (Get a postage-paid label (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/post_paid-affranchi-eng.php)):

Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, ON, Address Locator 0701E
K1A 0K9

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