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U.S. Department of Health and Human Services

Safety

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Varenicline (marketed as Chantix)

Audience: Neuropsychiatric and other healthcare professionals, consumers

[Posted 02/01/2008] FDA informed healthcare professionals and consumers of important revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for Chantix regarding serious neuropsychiatric symptoms experienced in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy. See the FDA Information for Healthcare Professionals Sheet for recommendations and considerations for healthcare professionals on using Chantix therapy for patients.

[February 01, 2008 - Public Health Advisory - FDA]
[February 01, 2008 - Prescribing Information - Pfizer]
[February 01, 2008 - Healthcare Professional Information Sheet - FDA]