Statement regarding Champix

2012-148
October 5, 2012

Canadians expect the drugs they take have been rigorously inspected for safety and efficacy before they are allowed on the market and are actively monitored once they are approved. Health Canada takes this responsibility very seriously and has put in place a world-class system for both the pre-market approval and post-market surveillance of health products.

Champix is considered an effective smoking cessation aid when used as part of a support program for helping quit smoking.  At this time, Health Canada considers that the benefits of Champix, when used as directed on the label, continue to outweigh the risks.

Health Canada has conducted several systematic reviews of Champix. As a result of these reviews, the product labelling has been updated to include a more detailed description of the identified safety issues, along with precautions for patients and recommendations for health care professionals. These risks and labelling changes have been communicated to health professionals and the public. Patients are advised to immediately stop taking Champix and seek emergency medical care if they or their families/caregivers observe unusual thoughts, feelings or behaviours. Patients with questions or concerns regarding Champix should speak to their doctor or pharmacist.

Health Canada continues to monitor this product using all sources of available information for any additional adverse reactions of concern that may not already be labelled or not labelled sufficiently to reflect the current risk/benefit profile.

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