Pfizer, FDA Square Off on Chantix Psych Risk

October 15, 2014 5:00 PM

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The maker of the popular stop-smoking drug varenicline (Chantix), Pfizer, says new data indicate the risk of suicidality and other serious psychiatric events is not as great as once thought, and has applied to the FDA to remove a boxed warning on those risks.

But in briefing documents for an FDA advisory committee meeting scheduled for Thursday, members of the agency's technical staff said those data had major limitations and that, at least for now, the boxed warning should stay.

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