Varenicline Isn't Associated with Depression, Suicidal Behavior, or Death

Varenicline (Chantix) is effective for achieving smoking cessation. However, since 2009, the FDA has required a black box warning on varenicline about possible neuropsychiatric adverse events. In this meta-analysis of 39 randomized controlled trials (duration, 1–52 weeks) that involved 11,000 long-term smokers (average use, 20 cigarettes daily for 26 years), investigators determined whether excess neuropsychiatric adverse events were associated with varenicline use. Maximum varenicline dose was 1 mg twice daily.

Risks for suicide or attempted suicide, suicidal ideation, depression, irritability, aggression, and death were similar in varenicline users and placebo users. Compared with placebo users, varenicline users had significantly higher r…