Varenicline use related to depression and suicidal behavior

January 01, 0001

Varenicline use related to depression and suicidal behavior

Two treatments for smoking cessation—varenicline and bupropion—carry Boxed Warnings from the U.S. Food and Drug Administration (FDA) about suicidal/self-injurious behavior and depression. However, some epidemiological studies report an increased risk in smoking or smoking cessation independent of treatment, and differences between drugs are unknown. From the FDA's Adverse Event Reporting System (AERS) database from 1998 through September 2010 the reserachers selected domestic, serious case reports for varenicline (n = 9,575), bupropion for smoking cessation (n = 1,751), and nicotine replacement products (n = 1,917).

A composite endpoint of suicidal/self-injurious behavior or depression was defined as a case with one or more Preferred Terms in Standardized MedDRA Query (SMQ) for those adverse effects. The main outcome measure was the ratio of reported suicide/self-injury or depression cases for each drug compared to all other serious events for that drug.

Overall they identified 3,249 reported cases of suicidal/self-injurious behavior or depression, 2,925 (90%) for varenicline, 229 (7%) for bupropion, and 95 (3%) for nicotine replacement. Compared to nicotine replacement, the disproportionality results (OR) were varenicline 8.4 and bupropion 2.9. The disproportionality persisted after excluding reports indicating concomitant therapy with any of 58 drugs with suicidal behavior warnings or precautions in the prescribing information. An additional antibiotic comparison group showed that adverse event reports of suicidal/self- injurious behavior or depression were otherwise rare in a healthy population receiving short-term drug treatment.

This has certainly been reported earlier but this association is stronger.

For the full abstract, click here.

PLoS ONE 6(11):e27016, 2 November 2011 © 2011 Moore et al
Suicidal Behavior and Depression in Smoking Cessation Treatments. Thomas J. Moore, Curt D. Furberg, Joseph Glenmullen et al. Correspondence to Thomas Moore: tmoore@ismp.org

Category: P. Psychological, R. Respiratory, Keywords: suicidal behavior, depression, smoking cessation, varenicline, bupropion, nicotine replacement, database analysis, journal watch.
Synopsis edited by Dr Stephen Wilkinson, Melbourne, Australia. Posted on Global Family Doctor 2 December 2011

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