WASHINGTON -- New government-approved labeling on Pfizer’s drug Chantix suggests that the anti-smoking medication may not carry the risks of suicidal behaviour that first earned it the Food and Drug Administration’s strongest warning more than five years ago.
The FDA updated the drug’s label Monday to include data from a number of recent studies that found little to no evidence of psychiatric problems or suicidal tendencies in patients taking the twice-a-day tablet.
The new labeling represents a victory for Pfizer Inc., which requested the update. Company executives say they will now ask the FDA to completely remove the drug’s so-called “black box” label -- the strongest type -- which warns prescribers of links to hostility, agitation, depression and suicidal behaviour.
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