Canada Issues Another Chantix WarningJan 7, 2009 | Parker Waichman LLP
Health regulators in Canada have issued another Chantix warning. Health Canada said the new alert was meant to serve as a reminder to consumers that it is still in the process of further strengthening the labeling for Chantix with respect to the risk of serious psychiatric adverse effects.
Chantix (sold as Champix in Canada) works by blocking nicotine receptors to the brain. When it was first introduced, Chantix was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy. But the drug has been linked to disturbing side effects, including suicidal thoughts and behavior.
Last February, the U.S. Food & Drug Administration (FDA) said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” Chantix maker Pfizer elevated 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.
The Canadian Product Monograph for Chantix was first updated in December 2007 and again in May 2008 to reflect important safety information related to serious psychiatric side-effects. Yesterday, Health Canada said it was issuing its latest Chantix reminder because the New Year often prompts people to undertake anti-smoking efforts. The agency said anyone considering using Chantix should:
- Be aware of any unusual thoughts, feelings or behaviors, especially those related to depression, aggression or self-harm. Patients should stop the drug immediately if there are such concerns.
- Tell a doctor if they have experienced depression or other mental health problems before taking Chantix, as these symptoms may worsen while taking the drug.
- Avoid driving a car or operating hazardous machinery until they are reasonably certain that Chantix does not affect them adversely.
In the U.S. Chantix continues to be the subject of numerous side effect reports. Just this past October, a report issued by the non-profit Institute for Safe Medication Practices found that in the first quarter of 2008, the FDA received more serious side effect reports for Chantix than for any other medication. According to the Institute, the Chantix side effects reported in that time frame included 50 deaths, 52 cases that may have involved various kinds of blackouts, and 15 adverse events that were linked to road traffic accidents.