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Canada Concerned Over Chantix Labeling Norms

Jan. 10, 2009

Canada is quite serious about the labeling norms of anti- smoking drug Chantix. Health regulators in Canada have issued another Chantix warning which was meant to ensure that it is still in the process of further strengthening the labeling norms for Chantix with respect to the risk of serious psychiatric adverse effects.

Chantix, the popular smoking cessation drug functions 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.