FDA first informed the public about the possibility of serious neuropsychiatric symptoms in the November 20, 2007 FDA Early Communication About an Ongoing Safety Review. At that time, information about serious neuropsychiatric symptoms in patients taking Chantix was added to the POST-MARKETING EXPERIENCE section of the prescribing information. As FDA’s review of the issue has progressed, it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms. As a result, FDA requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information to the WARNINGS and PRECAUTIONS sections of the Chantix prescribing information. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients.

This information reflects FDA's current analysis of data available concerning this drug. FDA is not advising practitiones to discontinue prescribing the product and intends to provide updated information when it becomes available.