While Chantix was approved 10 years ago, the FDA placed the “black box” warning on the drug’s label in 2009 after thousands of users reported mental health side effects.
The panel voted 10-19 that the warning — which highlights psychiatric risks like suicidal thoughts, hostility and agitation — should be removed from Chantix’s label. Of the nine panelists that voted no, four wanted to update the language on the label, while five recommended keeping the warning on the label as is.
Earlier this week, the FDA pointed out inconsistencies in New York-based Pfizer’s study about Chantix’s relationship to mental health risks. However, an FDA analysis of the trial’s results, excluding unreliable data, aligned with Pfizer’s findings that Chantix does not significantly increase the prevalence of mental health side effects in users.
While the FDA is not compelled to follow the advisory committee’s advice, it typically does.
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