US Food and Drug Administration (FDA) Drug Safety Communication: FDA revises description of mental health side effects of stop-smoking medicines varenicline and bupropion to reflect clinical trial findings

FDA have determined the risk of serious side effects on mood, behaviour, or thinking with varenicline and bupropion is lower than previously suspected. Subsequently, the FDA have removed the “Boxed warning” from the drug labels in the US.

In 2009, the Medicines and Healthcare products Regulatory agency published a Drug Safety Update reporting on a cohort study which looked at whether varenicline was associated with an increased risk of suicidal behaviour vs. bupropion or nicotine replacement therapy. The study found no clear evidence of an increased risk with varenicline.