Chantix was approved by the FDA on 11 May 2006. A study published by Thomas Moore and his colleagues at the non-profit Institute for Safe Medication Practices found that by the fourth quarter of 2007, Chantix surpassed all other drugs for serious events reported to the FDA, including but not limited to hostility, aggression, paranoia, hallucinations, psychosis, heart arrhythmias, heart attacks, visual disturbances, seizures, falls, traffic accidents, homicidal ideation, suicidal ideation, and suicide attempts, along with 28 actual suicides.
The Institute notified the FDA, which on 1 July 2009 issued an alert and required Pfizer to include a black box warning -- the strongest sanction possible short of banning a drug -- on all packages of Chantix, cautioning users and health professionals to be on the lookout forchanges in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, and attempted suicide.
