The neuropsychiatric risks of smoking cessation drugs may have been overstated, according to an FDA-requested study. Varenicline (Chantix) and bupropion (Wellbutrin) were compared to the nicotine patch and placebo with regard to efficacy and side effects. Of the more than 8,100 patients who were randomized, roughly half had a history of psychiatric disorders. In the non-psychiatric cohort, the rate of neuropsychiatric adverse events were 1.3%, 2.2%, 2.5%, and 2.4% in the varenicline, bupropion, nicotine, and placebo groups, respectively. The rates in the psychiatric group were 6.5%, 6.7%, 5.2%, and 4.9%, respectively. Varenicline was the most effective modality in achieving smoking abstinence. The authors concluded, “The study did not show a significant increase in neuropsychiatric adverse events attributable to varenicline or bupropion relative to nicotine patch or placebo.” (Lancet published online April 22, 2016. doi: http://dx.doi.org/10.1016/S0140-6736(16)30272-0).
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