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