Varenicline as a Cause of Suicidal Outcomes

Postmarketing analyses and case reports have associated varenicline use with suicidal behaviors. This article reviews postmarketing analyses, case reports, clinical trials, uncontrolled observational studies, controlled observational studies, and studies in smokers with psychiatric problems that have tested this association. The author searched the literature for relevant reports via computer and other searches to undertake a qualitative, systematic review. Two pooled analyses of 10 and 17 placebo-controlled trials failed to find more suicidal outcomes in the varenicline condition. Seven large uncontrolled observational studies reported low rates of suicide outcomes in varenicline users (