Testimony Before the FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Regarding the Black Box Warning on the Smoking Cessation Drug Varenicline (Chantix)

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In testimony presented at a joint meeting of the Food and Drug Administration’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee discussing whether to remove a boxed warning on the smoking cessation drug varenicline (Chantix), Public Citizen urged the committees to retain the boxed warning as a critical reminder to patients and their doctors that varenicline can cause potentially life-threatening psychiatric and neurologic side effects. The committees are considering whether to remove the boxed warning based on a single clinical trial that was fundamentally flawed and incapable of detecting the increased risk of such side effects, thousands of which have been reported to the FDA since varenicline’s approval in 2006.

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