Special Alerts:

[UPDATE 05/16/2008] FDA informed healthcare professionals and patients that as the Agency’s review of varenicline (Chantix) safety data has progressed, it appears increasingly likely that there is an association between varenicline and serious neuropsychiatric symptoms. Prescribing information for varenicline was revised to include this safety information in the WARNINGS and PRECAUTIONS sections of the label, and a Medication Guide for patients is also available. If patients, their families, or caregivers notice agitation, depressed mood, or changes in behavior that are not typical for the patient or if the patient has suicidal thoughts or actions, the patient should stop taking varenicline and contact their healthcare professional. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Chantix, http://www.fda.gov/cder/foi/label/2008/021928s008lbl.pdf, http://www.fda.gov/cder/drug/infopage/varenicline/default.htm, http://www.fda.gov/cder/Offices/ODS/MG/ChantixMG.pdf, http://www.fda.gov/cder/drug/InfoSheets/HCP/vareniclineHCP.htm, http://www.fda.gov/cder/drug/early_comm/varenicline.htm, http://www.fda.gov/medwatch/safety/2007/Chantix_PI.pdf.

[Posted 02/01/2008] FDA informed healthcare professionals and consumers of important revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for varenicline tartrate (Chantix) regarding serious neuropsychiatric symptoms experienced in patients taking varenicline tartrate. 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 varenicline tartrate who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking. In most cases, neuropsychiatric symptoms developed during varenicline tartrate treatment, but in others, symptoms developed following withdrawal of varenicline tartrate therapy. See the FDA Information for Healthcare Professionals Sheet for recommendations and considerations for healthcare professionals on using varenicline tartrate therapy for patients. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Varenicline, http://www.fda.gov/cder/drug/advisory/varenicline.htm, http://www.fda.gov/cder/foi/label/2008/021928s007lbl.pdf and http://www.fda.gov/cder/drug/InfoSheets/HCP/vareniclineHCP.htm.

[Posted 11/20/2007] FDA informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patient who have taken varenicline (Chantix), a smoking cessation product. There are also reports of patients experiencing drowsiness that affected their ability to drive or operate machinery. FDA is currently reviewing these cases, along with other recent reports. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating varenicline treatment. The role of varenicline in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in the cases had preexisting psychiatric illness and not all had discontinued smoking.

Healthcare professionals should monitor patients taking varenicline for behavior and mood changes. Patients taking this product should report behavior or mood changes to their doctor and use caution when driving or operating machinery until they know how quitting smoking with varenicline may affect them. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Chantix and http://www.fda.gov/cder/drug/early_comm/varenicline.htm.