Varenicline Use and Risk for Self-Harm and Suicide

Postmarketing reports have linked varenicline (Chantix), a smoking cessation drug, with depression and suicide; in 2009, the FDA required a boxed warning to be placed in the product information for varenicline. In this observational cohort study, U.K. investigators examined the association between varenicline use (compared with bupropion use or nicotine replacement) and suicidal behavior or suicide.

Using a primary care database, researchers identified more than 80,000 adults who received initial courses of varenicline (10,973 patients), bupropion (6422), or nicotine replacement (63,265) from 2006 through 2008. Follow-up continued until 3 months after the last prescription or when the primary endpoint (nonfatal self-harm or suicide) occurred…