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FDA panel: Keep black box on Pfizer's Chantix

This article was originally published in Scrip

Executive Summary

A majority of an FDA panel of advisers on 16 October recommended retaining the black-box warning on the labeling of Pfizer's anti-smoking aid Chantix (varenicline), which alerts prescribers and patients about the risk of serious neuropsychiatric events, and reassessing it once results are available from an ongoing postmarketing study, expected in August 2016.

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