A new study finds that popular smoking cessation drugs varenicline (Chantix) and bupropion (various brands), “show no significant increase in the risk for serious neuropsychiatric side effects in patients with or without psychiatric disorders”.
The largest to date study examined the “safety and efficacy of the two drugs in comparison with nicotine patch and placebo,” was taken on based on a request by the US Food and Drug Administration (FDA), which requires a black box warning on the two drugs, owing to concerns of neuropsychiatric side effects.
Published online in Lancet, the study was conducted between 2011 and 2015 and examined over 8000 smokers who were motivated to quit, from 16 different countries. Participants were grouped into those with current or past stable psychiatric disorders and those without such disorders.
Study participants were randomly assigned to “receive 12 weeks of treatment with either varenicline, bupropion nicotine patch, or placebo, with 12 weeks of non-treatment follow-up. It was also noted that participants also received cessation counseling at each visit.
Of those studied who had no previous psychiatric disorders, “there were no statistically significant differences between any of the treatment groups in rates of moderate and severe neuropsychiatric disorders.” For those participants who had been previously diagnosed with a psychiatric disorders or were currently dealing with any, “rates of moderate and severe neuropsychiatric adverse events were higher in general.”