Intended for healthcare professionals


Mental health effects of varenicline

BMJ 2015; 350 doi: (Published 17 March 2015) Cite this as: BMJ 2015;350:h1168
  1. Mira Harrison-Woolrych, honorary research associate professor
  1. 1Dean’s Department, Dunedin School of Medicine, University of Otago, New Zealand
  1. miraharrison-woolrych{at}

Results from a new meta-analysis seem at odds with patients’ real life experiences

The safety of drugs for smoking cessation, in particular varenicline (Chantix, Champix; Pfizer) and its effects on mental health, has been debated by regulatory authorities, researchers, prescribers, and patients since varenicline was first marketed nine years ago. The debate is likely to be sharpened by the linked paper by Thomas and colleagues (doi:10.1136/bmj.h1109), a systematic review and meta-analysis of randomised placebo controlled trials that found “no evidence of an increased risk of suicide or attempted suicide, suicidal ideation, depression, or death with varenicline.”1 This finding seems to be at odds with many patients’ experience of psychiatric adverse effects associated with varenicline, recently summarised in a citizen petition to the US Food and Drug Administration (FDA).2 It is timely to assess where the balance of evidence lies so that patients struggling to stop smoking can be advised about the risks of varenicline and consensual decisions about treatment can be made.

Mental health effects of varenicline—including depression, suicidal behaviour, and psychotic reactions—have been reported worldwide3 4 5 6 and are documented on the product information, including a “black box” warning on the Chantix label.7 Since the addition of these warnings in …

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