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Pfizer’s Chantix Label Gets Black Box Warning

The FDA has mandated that Pfizer update the U.S. product labeling for Chantix, a smoking cessation treatment, with safety information in a black box warning as well as revised warnings and precautions.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The FDA has mandated that Pfizer update the U.S. product labeling for Chantix, a smoking cessation treatment, with safety information in a black box warning as well as revised warnings and precautions. The updated label, based on post-marketing reports, highlights safety information about reports of neuropsychiatric events and updates the warning about reports of neuropsychiatric symptoms and suicidality. It also adds warnings about reports of allergic reactions and serious skin reactions, an...

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