Published 1 October 2009, doi:10.1136/bmj.b3805
Cite this as: BMJ 2009;339:b3805

Research

Varenicline and suicidal behaviour: a cohort study based on data from the General Practice Research Database

¹ University of Bristol, Department of Social Medicine, University of Bristol, Bristol BS8 2PS, ² Vigilance and Risk Management of Medicines, Medicines and Healthcare products Regulatory Agency, London SW8 5NQ

Objective To determine whether varenicline, a recently licensed smoking cessation product, is associated with an increased risk of suicide and suicidal behaviour compared with alternative treatments bupropion and nicotine replacement therapy.

Design Cohort study nested within the General Practice Research Database.

Setting Primary care in the United Kingdom.

Participants 80 660 men and women aged 18-95 years were prescribed a new course of a smoking cessation product between 1 September 2006 and 31 May 2008; the initial drugs prescribed during follow-up were nicotine replacement products (n=63 265), varenicline (n=10 973), and bupropion (n=6422).

Main outcome measures Primary outcomes were fatal and non-fatal self harm, secondary outcomes were suicidal thoughts and depression, all investigated with Cox’s proportional hazards models.

Results There was no clear evidence that varenicline was associated with an increased risk of fatal (n=2) or non-fatal (n=166) self harm, although a twofold increased risk cannot be ruled out on the basis of the upper limit of the 95% confidence interval. Compared with nicotine replacement products, the hazard ratio for self harm among people prescribed varenicline was 1.12 (95% CI 0.67 to 1.88), and it was 1.17 (0.59 to 2.32) for people prescribed bupropion. There was no evidence that varenicline was associated with an increased risk of depression (n=2244) (hazard ratio 0.88 (0.77 to1.00)) or suicidal thoughts (n=37) (1.43 (0.53 to 3.85)).

Conclusion Although a twofold increased risk of self harm with varenicline cannot be ruled out, these findings provide some reassurance concerning its association with suicidal behaviour.

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    StumbleUpon    Technorati    What's this?

Relevant Articles

Smoking cessation agents and suicide

Jill E Lavigne
BMJ 2009 339: b4360. [Extract] [Full Text]

Antidepressant treatment and the risk of fatal and non-fatal self harm in first episode depression: nested case-control study

Carlos Martinez, Stephan Rietbrock, Lesley Wise, Deborah Ashby, Jonathan Chick, Jane Moseley, Stephen Evans, and David Gunnell
BMJ 2005 330: 389. [Abstract] [Full Text] [PDF]

Suicide, deprivation, and unemployment: record linkage study

Glyn Lewis and Andy Sloggett
BMJ 1998 317: 1283-1286. [Abstract] [Full Text] [PDF]

Validation of information recorded on general practitioner based computerised data resource in the United Kingdom.

H Jick, S S Jick, and L E Derby
BMJ 1991 302: 766-768. [Abstract] [PDF]

This article has been cited by other articles:

• Lavigne, J. E (2009). Smoking cessation agents and suicide. BMJ 339: b4360-b4360 [Full text]  
• (2009). Varenicline Use and Risk for Self-Harm and Suicide. JWatch General 2009: 1-1 [Full text]  

Rapid Responses:

Read all Rapid Responses

Varenicline and the risk of psychiatric side effects

Thomas J. Moore, et al.
bmj.com, 18 Oct 2009 [Full text]

No significant efficacy difference between NRT & varenicline

John R. Polito
bmj.com, 22 Oct 2009 [Full text]

Authors' response

David Gunnell, et al.
bmj.com, 4 Nov 2009 [Full text]

Online poll

Find out more on doc2doc >>