Varenicline and the risk of psychiatric conditions, suicide, crime and RTA

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Read the full open access research: http://www.bmj.com/content/350/bmj.h2388

Varenicline (marketed as Champix or Chantix), is prescribed to help people quit smoking.

After varenicline’s introduction on the market, reports of suicidality and depression emerged in post-marketing surveillance and eventually led to warnings issued by regulatory agencies in Europe and a black box warning in the United States. Furthermore, varenicline has been reported to increase the risk of traffic accidents, and it has been restricted or prohibited in several transportation industry professions, including pilots, air traffic controllers, truck and bus drivers, and certain military personnel. Some weaker evidence also suggests an increased risk of violence and psychosis.

However, these increased risks are based on post-marketing surveillance and case reports, which are not consistent with observational data and randomised controlled trials that have found no association between varenicline and depression, suicidality, or violence. These inconsistencies could be explained by differences in study designs, confounding by comorbid psychiatric disorders or by indication bias (that is, the same factors may influence both institution of treatment and outcomes), or reporting bias. Moreover, people with mental health problems make up a substantial proportion of smokers. Although no safety concerns have been raised in randomised controlled trials of varenicline in people with bipolar disorder, major depression, and schizophrenia, trials have comprised small samples, resulting in limited statistical power to detect rare events.

In this study the author's used data from the whole population of Sweden to examine associations between varenicline and the incidence of a range of adverse outcomes.

The conclude that concerns that varenicline is associated with an increased risk of many adverse outcomes, including suicidality and accidents, are not supported in this observational study. The small increase in risk of two psychiatric conditions in people with pre-existing psychiatric disorders needs to be confirmed using other research designs.

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