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

D Gunnell¹, D Irvine, L Wise

¹University of Bristol, Department of Social Medicine, University of Bristol, Bristol BS8 2PS. d.j.gunnell@bristol.ac.uk

BMJ (Clinical Research Ed.)

|October 3, 2009

Summary

Varenicline, a smoking cessation aid, does not show a clear increased risk of suicide or self-harm compared to other treatments. Further research is needed, but current findings offer some reassurance regarding its safety profile.

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Area of Science:

Pharmacovigilance
Public Health
Clinical Research

Background:

Varenicline is a prescription medication used for smoking cessation.
Concerns have been raised about its potential association with suicidal behavior.
Comparative safety data with other smoking cessation aids are crucial for clinical decision-making.

Purpose of the Study:

To evaluate the association between varenicline use and the risk of suicide and suicidal behavior.
To compare these risks with those associated with bupropion and nicotine replacement therapy (NRT).
To provide evidence-based information on the safety of varenicline for smoking cessation.

Main Methods:

A cohort study was conducted using the UK General Practice Research Database.
80,660 adult patients prescribed smoking cessation products (varenicline, bupropion, or NRT) between 2006 and 2008 were analyzed.
Cox proportional hazards models were used to assess primary outcomes (fatal/non-fatal self-harm) and secondary outcomes (suicidal thoughts, depression).

Main Results:

No clear evidence linked varenicline to increased fatal or non-fatal self-harm, though a twofold risk increase couldn't be excluded.
Varenicline's hazard ratio for self-harm was 1.12 (95% CI 0.67 to 1.88) compared to NRT.
No significant association was found between varenicline and increased depression or suicidal thoughts.

Conclusions:

While a twofold increased risk of self-harm with varenicline remains a possibility, the study provides some reassurance.
The findings suggest varenicline is not clearly associated with a heightened risk of suicidal behavior compared to NRT and bupropion.
Further investigation may be warranted, but current data support the cautious use of varenicline in smoking cessation programs.