OBJECTIVE: To assess a possible relationship between treatment with bupropion 
(vs placebo) and expressed suicidal ideation and behavior.
DATA SOURCES: This analysis, based on the US Food and Drug Administration's 
(FDA's) analysis of antidepressant suicidality data, included 8,953 adult 
subjects receiving bupropion and 6,520 adult subjects receiving placebo from 
randomized, placebo-controlled trials with bupropion conducted between 1976 and 
2006 across multiple indications, including major depressive disorder (MDD). A 
text string search of the adverse event database and case report form comments 
was performed to identify potential suicidal events. FDA search criteria 
included the following text strings: accident-, injur-, suic-, or overdos-, 
including all events coded as accidental overdose, attempt, cut, gas, hang, 
hung, jump, mutilat-, self damag-, self harm, self inflict-, shoot, slash, 
poison, asphyxiation, suffocation, firearm, burn, drown, gun, immolat-, and 
monoxide, and the following terms were added by GlaxoSmithKline to the search 
criteria: accident, lacerat-, MVA, and hospital. The database search included 
data beginning from the first dose of study medication through 1 day following 
the last dose.
DATA EXTRACTION: Suicidal event narratives were classified using the Columbia 
Classification Algorithm for Suicide Assessment. Additionally, changes on rating 
scale items for depressed mood and suicidality were analyzed.
DATA SYNTHESIS: In the MDD population, the incidence of suicidal behavior or 
ideation was 17/3,179 (0.53%) versus 11/2,310 (0.48%) for the bupropion and 
placebo groups, respectively (OR = 1.28; 95% CI, 0.59-2.86). For suicidal 
behavior, the incidence was 8/3,179 (0.25%) versus 2/2,310 (0.09%), respectively 
(OR = 3.52; 95% CI, 0.81-24.48). No suicidal behavior event was noted in the 
other indications, and no completed suicides were reported during treatment. No 
significant worsening was observed for bupropion relative to placebo on the 
rating scale items. No differential treatment effects were observed by gender or 
age; regardless of treatment, however, the 18- to 24-year-old group had the 
greatest odds of having a suicide event.
CONCLUSIONS: Although no statistically significant differences were observed 
between bupropion and placebo in expressed suicidal ideation or behavior, we 
believe that all patients treated with antidepressants should receive careful 
monitoring for clinical worsening, suicidality, or unusual changes in behavior.