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Varenicline is one of our most effective smoking cessation pharmacotherapies.1 However, postmarketing reports of neuropsychiatric adverse events led the US Food and Drug Administration to issue a warning of potential increased risk of depression, suicidality, agitation and hostility (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170100.htm). These reports usually lack the medical history and circumstantial details required for proper adjudication. Moreover, because patients with psychiatric disorders were excluded from pivotal varenicline trials and because changes in negative affect are expected during nicotine withdrawal it was difficult to gauge the risk in this potentially vulnerable group.
In total, 525 smokers with stably treated current or past major depression …
Competing interests PMC is a site principal investigator and MK-H a co-investigator on a clinical trial sponsored by Pfizer. They have also received grants and non-financial support from Pfizer, including medication for a National Institutes of Health (NIH)-funded trial.