CHAMPIX
ATC Code
N07BA03
Warning
Health Canada Endorsed Important Safety Information on CHAMPIX (varenicline tartrate)
Pfizer Canada in collaboration with Health Canada would like to notify healthcare professionals of important safety information regarding CHAMPIX, and post-marketing reports of serious neuropsychiatric adverse events, including depressed mood, agitation, hostility, changes in behaviour, suicidal ideation and suicide, as well as worsening of pre-existing psychiatric illness (previously diagnosed or not). Since the introduction of CHAMPIX in Canada, in April 2007 through April 30, 2008, a total of 226 Canadian cases of neuropsychiatric adverse events have been reported. For the same time period, there have been 708 534 prescriptions filled for CHAMPIX in Canada1.
* All patients attempting to quit smoking with CHAMPIX, their families and caregivers should be alerted about the need to monitor for symptoms of neuropsychiatric adverse events.
* Patients should be instructed to stop taking CHAMPIX and contact their healthcare provider immediately if they have or if their families or caregivers observe depressed mood, agitation, hostility or changes in behavior, that are not typical for the patient, or if the patient has suicidal ideation or suicidal behavior.
* Patients with concomitant psychiatric conditions, even if well controlled, or with a history of psychiatric symptoms, should be diligently monitored.
It is important to note that smoking cessation with or without treatment is associated with various symptoms. For example, dysphoric or depressed mood, insomnia, irritability, frustration, anger or hostility, anxiety, difficulty concentrating, restlessness, decreased heart rate, increased appetite or weight gain have been reported in patients attempting to stop smoking.
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