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Pfizer's Pitch For Chantix Warning Reduction Focuses On Those With Mental Illness

 
• By Derrick Gingery

Those patients need more options for smoking cessation, Pfizer says, but that is the group FDA most worries about when deciding whether to remove its boxed warning.

Pfizer's pitch to remove the boxed warning from its smoking cessation drug Chantix (varenicline) focuses in part on its importance to smokers with mental illness, a group that appears one of FDA's major concerns as it reviews the company’s safety data.

At an advisory committee in September, Pfizer Inc. and its outside experts highlighted psychiatric patients as a group in need of help quitting smoking and argued that the boxed warning, which details the potential for neuropsychiatric adverse events, deters its use

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