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  3. Varenicline and risk of psychiatric conditions, suicidal behaviour, criminal offending, and transport accidents and offences: population based cohort study
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Research

Varenicline and risk of psychiatric conditions, suicidal behaviour, criminal offending, and transport accidents and offences: population based cohort study

BMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h2388 (Published 02 June 2015) Cite this as: BMJ 2015;350:h2388
  1. Yasmina Molero, postdoctoral research associate1,
  2. Paul Lichtenstein, professor2,
  3. Johan Zetterqvist, PhD student2,
  4. Clara Hellner Gumpert, associate professor1,
  5. Seena Fazel, Wellcome Trust senior research fellow in clinical science3
  1. 1Department of Clinical Neuroscience, Center for Psychiatry Research, Karolinska Institutet, 171 76 Stockholm, Sweden
  2. 2Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Box 281, 171 77 Stockholm
  3. 3Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford OX3 7JX, UK
  1. Correspondence to: S Fazel seena.fazel{at}psych.ox.ac.uk
  • Accepted 30 March 2015

Abstract

Objective To examine associations between varenicline and the incidence of a range of adverse outcomes.

Design Population based cohort study using within person analyses to control for confounding by indication.

Setting Whole population of Sweden.

Participants 7 917 436 people aged 15 and over, of whom 69 757 were treated with varenicline between 2006 and 2009.

Main outcome measures Incidence of new psychiatric conditions, suicidal behaviour, suspected and convicted criminal offending, transport accidents, and suspected and convicted traffic offences.

Results In the whole population, 337 393 new psychiatric conditions were diagnosed during follow-up. In addition, 507 823 suspected and 338 608 convicted crimes, 40 595 suicidal events, 124 445 transport accidents, and 99 895 suspected and 57 068 convicted traffic crimes were recorded. Within person analyses showed that varenicline was not associated with significant hazards of suicidal behaviour, criminal offending, transport accidents, traffic offences, or psychoses. However, varenicline was associated with a small increase in the risk of anxiety conditions (hazard ratio 1.23, 95% confidence interval 1.01 to 1.51) and mood conditions (1.31, 1.06 to 1.63), which was only seen in people with pre-existing psychiatric disorders.

Conclusions 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.

Footnotes

  • Contributors: YM was involved in the conception of the study, analysis and interpretation of the data, and writing the manuscript. SF was involved in the conception of the study, interpretation of the data, and writing the manuscript. JZ was involved in the study design and in analysis and interpretation of the data. PL and CHG were involved in study conception and interpretation of the data. All authors were involved in revising the article critically for important intellectual content and final approval of the version to be published. SF is the guarantor.

  • Funding: Funding for this study was provided by the Wellcome Trust (095806); Karolinska Institutet; the Swedish Research Council for Health, Working Life and Welfare; and the Swedish Research Council. The funders had no further role in the study design; in the collection, analysis, and interpretation of data; or in the writing of the paper.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work other than that described above; SF has received travel expenses from Janssen to attend one conference unrelated to the submitted work; no other relationships or activities that could appear to have influenced the submitted work.

  • Ethical approval: This study was approved by the ethical committee of Karolinska Institutet (2005/4:5).

  • Transparency declaration: The lead author (the manuscript’s guarantor) affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.

  • Data sharing: No additional data available.

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See http://creativecommons.org/licenses/by/4.0/.

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