Health Canada Reminds Canadians of Important Safety Information For the Smoking-Cessation Aid Champix

Health Canada Reminds Canadians of Important Safety Information For the Smoking-Cessation Aid Champix

Information Update2009-01

OTTAWA - Health Canada is reminding Canadians who are taking, or considering taking, the smoking-cessation aid Champix of important safety information for this product. Health Canada is also informing Canadians that it is in the process of further strengthening the labelling for the drug with respect to the risk of serious psychiatric adverse effects.

While Champix (the brand name for varenicline tartrate) can be an effective tool for quitting smoking when used as part of a support program, there have been reports in some patients of unusual feelings of agitation, depressed mood, hostility, changes in behaviour, or impulsive or disturbing thoughts such as thoughts of self-harm or harm to others. It is unclear at this time whether Champix is the cause of these psychiatric symptoms.

At this time of year when many people consider giving up smoking, Health Canada reminds Canadians using or thinking of using Champix of the following safety information for the drug:
Patients taking Champix, as well as their families and friends, are reminded to be aware of any unusual thoughts, feelings or behaviours, especially those related to depression, aggression or self-harm. Patients should stop the drug immediately if there are such concerns. Tell your doctor if you have experienced depression or other mental health problems before taking Champix, as these symptoms may worsen while taking the drug. Patients are also reminded to avoid driving a car or operating hazardous machinery until they are reasonably certain that Champix does not affect them adversely. Health Canada is currently working with Pfizer, the manufacturer of Champix, to update the prescribing information to reflect current safety information. This update is the result of continuing reports, in Canada and internationally, of serious psychiatric symptoms associated with the use of Champix, and is intended to increase awareness of this risk. Label changes will be communicated to consumers and health care professionals when finalized.

There are a number of options, with and without prescription medicines, available to Canadians considering stopping smoking. Health Canada reminds consumers thinking of quitting to talk first 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 in the Quit Smoking Now section of the Health Canada Web site.

The Canadian Product Monograph for Champix was first updated in December 2007 and again in May 2008 to reflect important safety information related to the serious psychiatric side-effects described above. Additional information on these Product Monograph updates is available in the MedEffect ™ Canada section of the Health Canada Web site, including information for the public, and information for health care professionals. The Product Monograph is available, by search, from the online Drug Product Database (DPD).

Consumers requiring more information about this advisory can contact Health Canada's public inquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

You can report any adverse reactions associated with the use of Champix to the Canada Vigilance Program by one of the following three ways:

Report online at the MedEffect ™ Canada section of the Health Canada Web site Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and either: Fax toll-free to 1-866-678-6789 Mail to: Canada Vigilance Program Health CanadaAL 0701COttawa, ON K1A 0K9