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

Jump to full article: British Medical Journal, 2009-10-01

Intro:

Main findings

We found no clear evidence of an increased risk of self harm associated with varenicline compared with other smoking cessation products, although the limited study power means we cannot rule out either a halving or a twofold increase in risk. Analysis of those patients prescribed varenicline suggested that they were likely to be at lower risk of self harm than those prescribed nicotine replacement products—they had lower levels of past psychiatric consultation and previous self harm.

Nevertheless, controlling for these factors in multivariable models did not alter our conclusions.Wefound no evidence that varenicline increased the incidence of suicidal thoughts. However, associations with suicidal thoughts should be treated with caution as they are under-recorded in the General Practice Research Database (GPRD). Varenicline was associated with a reduced risk of treated depression, as indexed by initiation of antidepressant therapy. . . .

Conclusion

We found no clear evidence of an increased risk of self harm, suicidal thoughts, or depression in people prescribed varenicline compared with those prescribed other smoking cessation products. In view of increasing concerns about the possible increased risk of suicide associated with these drugs and their increasing popularity, further investigation of their effect on suicide risk is required in other databases and through secondary analysis of all adverse event reporting in relevant clinical trials. Any such risk must be balanced against the likely long term health benefits of smoking cessation and the robust evidence of the effectiveness of varenicline as an aid to smoking cessation.

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