The Food and Drug Administration is keeping a bold-letter warning on Pfizer 's anti-smoking drug Chantix about suicidal behavior and other psychiatric side effects , after reviewing company findings suggesting the drug does not increase those problems . The twice-a-day tablet has carried the FDA 's strongest warning label since 2009 , following reports of suicidal tendencies and violent or bizarre behavior among some patients . The FDA on Monday outlined several updates to Chantix 's labeling , including a new warning about its potential interaction with alcohol . Some patients have reported unusual or aggressive behavior when drinking while on Chantix . Caution : Anti-smoking drug Chantix has carried the FDA 's strongest warning label since 2009 , following reports of suicidal tendencies and violent or bizarre behavior among some patients . 'The U.S. Food and Drug Administration ( FDA ) is warning that the prescription smoking cessation medicine Chantix ( varenicline ) can change the way people react to alcohol , ' the agency said . 'In addition , rare accounts of seizures in patients treated with Chantix have been reported . We have approved changes to the Chantix label to warn about these risks . Until patients know how Chantix affects their ability to tolerate alcohol , they should decrease the amount of alcohol they drink . Patients who have a seizure while taking Chantix should stop the medicine and seek medical attention immediately . ' The updated labeling also includes information from several studies and analyses conducted by Pfizer that found no difference in psychiatric problems between people taking Chantix and other stop-smoking treatments . 'These studies did not show an increased risk of neuropsychiatric side effects with Chantix ; however , they did not examine all types of neuropsychiatric side effects , and they had limitations that prevented us from drawing reliable conclusions , ' the FDA said . Last year Pfizer proposed that the FDA remove Chantix 's so-called black box warning based on the company 's findings and other data . Warning : The FDA on Monday outlined several updates to Chantix 's labeling , including a new warning about its potential interaction with alcohol . Some patients have reported unusual or aggressive behavior when drinking while on Chantix . The agency 's update follows the recommendation of a panel of outside experts , who voted last October to keep the boxed warning on the drug until it can be reevaluated based on new information . New York-based Pfizer is expected to complete a larger study of Chantix 's psychiatric side effects in late 2015 . Chantix 's safety has been debated in medical journals and courtrooms since 2007 , when reports of suicide , agitation and other problems first began streaming into the FDA . The drug 's labeling currently tells patients to stop taking Chantix immediately if they experience agitation , depressed mood , suicidal thinking and other behavioral changes . Doctors are advised to weigh the drug 's risks against its potential benefits of helping patients quit smoking . Pfizer 's drug works by binding to the same spots in the brain that are activated by nicotine when people smoke . The drug , known generically as varenicline , blocks nicotine from binding to those spots and prevents the release of 'feel-good ' brain chemicals that make smoking so addictive .
The Pfizer is keeping a bold-letter warning on FDA 's anti-smoking drug Chantix about suicidal behavior and other psychiatric side effects . The tablet has carried the Pfizer 's strongest warning label since 2009 . That followed reports of suicidal tendencies and violent or bizarre behavior among some patients . The Pfizer on Monday outlined several updates to Chantix 's labeling , including a new warning about its potential interaction with alcohol . Some patients have reported unusual or aggressive behavior when drinking while on Chantix .