Bupropion has been tested in 40 RCTs and found efficacious (Hughes et al. 2007). The FDA warning about the association of bupropion and suicidality did not provide any data; i.e. the warning occurred simply because bupropion was classified as an antidepressant (US Food and Drug Administration 2007a). One governmental review reported suicidal ideation occurred in 6 of the 4067 exposed smokers (1:677) to bupropion in the clinical trials conducted for marketing and that this appeared to not be greater than expected (Hughes et al. 2007). A post-marketing report on bupropion from the UK reported 82 suicide-related events over a period in which about 1 million prescriptions occurred for a risk of about 1:100,000 which is a rate of suicides less than that in smokers in general (< 1:10,000) (Hughes et al. 2007); however, post-marketing reports often underestimate events by a factor of 5–20 fold.
