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Another Chantix Warning in Canada

Jun 24, 2008 | Parker Waichman Alonso LLP

For the second time since April, health officials in Canada have issued a warning about Chantix, Pfizer's anti-smoking medication.  This time, Health Canada is warning that Chantix - sold in Canada as Champix - has caused unusual feelings of agitation, depressed mood, hostility, changes in behavior or impulsive or disturbing thoughts, such as ideas of self-harm or of harming others, in some users.

In April, Health Canada issued an alert warning that Chantix has been linked to 107 adverse reactions in Canada.  According to the ageny nearly half of those reports involved psychiatric behavior.  In its latest alert, Health Canada has said that in the year following its approval, 226 Canadian cases of neuropsychiatric adverse events have been reported in patients taking the drug.

Health Canada also issued the following guidelines:

• People taking Chantix should tell their  doctor if they experienced depression or other mental health problems before taking Chantix, as these symptoms may worsen while taking the drug.
• Patients should stop taking Chantix and tell their doctor right away if they, their family or caregiver notice any of these symptoms, if they  experience these symptoms in a way that is not typical for them or if they have thoughts of self-harm or of harming others.
• Chantix has not been studied in people with mental health problems, and therefore a doctor should monitor such patients closely for new or worsened emotional or behavioral problems while on the medication.

In the US, Chantix has been linked to at least 40 suicides and 400 attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.  

In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.