Compared with other smoking-cessation treatments, the risk for suicidal behavior or depression was markedly increased with varenicline.


The safety of varenicline for smoking cessation continues to generate controversy. In a recent systematic review and meta-analysis, investigators analyzed data from 14 trials and found a significantly increased risk for cardiovascular events with varenicline. Now, a group that includes some of the same authors has evaluated data from the FDA's Adverse Event Reporting System (AERS) to compare the neuropsychiatric safety profiles of three smoking-cessation treatments: varenicline, bupropion, and nicotine-replacement products.

The AERS consists of case reports about serious adverse events that are sent to drug manufacturers or directly to the FDA. From 13,243 case reports on the three products, the investigators identified 3249 events described as suicidal/self-injurious behavior or depression. Of these events, 90% were associated with varenicline, 7% with bupropion, and 3% with nicotine replacement. Of the 295 completed suicides, 92% were associated with varenicline. Headache and pain events, which are not surmised to be associated with these drugs but are common symptoms of nicotine withdrawal, did not differ in prevalence among the three interventions.


Citation(s):

Moore TJ et al. Suicidal behavior and depression in smoking cessation treatments. PLoS ONE 2011 Nov 2; 6:e27016.