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In November 2007, the FDA announced it had received post-marketing reports that patients using Chantix for smoking cessation had experienced several serious symptoms, including suicidal ideation and occasional suicidal behavior, erratic behavior, and drowsiness. On February 1, 2008 the FDA issued an Alert to further clarify its findings, noting that "it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms." It is unknown whether the psychiatric symptoms are related to the drug or to nicotine withdrawal symptoms, although not all patients had stopped smoking. The FDA also recommended that health care professionals and patients watch for behavioral and mood changes.[7] In May 2008, Pfizer updated the safety information associated with Chantix, noting that "some patients have reported changes in behavior, agitation, depressed mood, suicidal thoughts or actions."

* On September 3, 2007, musician Carter Albrecht was shot and killed by his girlfriend's neighbor. Albrecht's girlfriend and others close to him have publicly claimed that Chantix contributed to the erratic behavior which led to his death. [18]

* On Thursday, May 22, 2008, The New York Times reported that the U.S. Federal Aviation Administration (F.A.A.) had announced the day before a ban on the use of Chantix (varenicline tartrate) for both pilots and air traffic controllers, due to concerns with possible adverse neuropsychiatric effects which could be detrimental to public safety.[19]

* On Sunday, May 25, 2008, The Los Angeles Times reported that over 2 dozen traffic accidents had been linked to Chantix and reported to the FDA. Warnings had previously been issued by Pfizer regarding the risks of Chantix while driving. However, these warnings have largely been ignored by doctors and patients.[20]

* On Tuesday, June 17, 2008, The Washington Times reported on its Front Page that the United States Department of Veterans Affairs was testing Chantix on war veterans with Post Traumatic Stress Disorder without properly warning them of the side effects, and that in one case a veteran was almost killed when he had a psychotic episode and threatened police officers.[21]

* On October 23, 2008, the Institute for Safe Medication Practices issued an analysis of prescription drug-related injuries reported to the FDA during the first quarter of 2008. According to the report, varenicline had more reported incidents than any other drug, with 1001 new cases of adverse effects and 50 more deaths reported. (Heparin, the drug with the second highest number of injury reports, had 779 new cases, most of which were connected to a contaminant inadvertently introduced into the drug in early 2008). In comparison, the ISMP reported that in the first quarter of 2008 there were 17 serious injury reports for nicotine-replacement products, and 44 reports for bupropion (sold as Zyban as a smoking cessation medication). Varenicline did not rank in the ten drugs with the most related deaths, but did rank first in reports of suicide or self-injury, with 228 reports citing these effects. The ISMP noted that the high number of varenicline-related injury reports may be related to the publicity surrounding the medication's potential side effects. [22]

* On January 15, 2009, the Institute for Safe Medication Practices issued its analysis of prescription drug-related injuries reported to the FDA during the second quarter of 2008. During this period there were 910 newly-reported cases of serious injury attributed to Varenicline, including 38 deaths. In addition to the above-reported psychiatric effects, the report noted increasing evidence linking Varenicline to "potentially life-threatening allergic reactions." According to the report, Varenicline had the second-highest number of new injury reports during this quarter. By comparison, Digoxin had the highest number, with 1882 injury reports and 650 associated deaths, the majority of which were linked to a manufacturing quality control problem and subsequent recall of the Digitek brand of Digoxin. [23]

* On February 4, 2009, Health Canada announced that it had received more than 800 complaints from Canadian users, many of them reporting mood swings, depression or suicidal thoughts.[24]

* On June 3, 2010, Health Canada announced changes to the Canadian Product Monograph that include changes in mood or behaviour (such as depressed mood, agitation, aggression, hostility, thoughts of self-harm or harm towards others); serious allergic reactions (such as swelling of the face, lips, gums, tongue and throat that can cause trouble breathing) and skin reactions (such as rash, swelling, redness, and peeling of the skin); neuropsychiatric side-effects have occurred in patients taking CHAMPIX with or without a history of psychiatric disorder; drinking alcohol may increase the risk of experiencing neuropsychiatric side effects; and side-effects such as sleepiness, dizziness, loss of consciousness, seizures, or difficulty concentrating may also occur. Patients should not engage in potentially hazardous activities, such as driving a car or operating dangerous machinery until they know how they may be affected by CHAMPIX.