FRIDAY, Oct. 2 (HealthDay News) -- The smoking cessation drug varenicline is likely not associated with increased risk of self-harm, although a two-fold increased risk cannot be ruled out, according to a study published Oct. 2 in BMJ.
David Gunnell, Ph.D., of the University of Bristol in the United Kingdom, and colleagues conducted a study of 80,660 men and women aged 18 to 95 years who were prescribed a course of smoking cessation treatment, including 63,265 prescribed nicotine replacement therapy, 10,973 prescribed varenicline, and 6,422 prescribed bupropion.
There were two cases of fatal and 166 cases of nonfatal self-harm, and there was no evidence of increased risk for those prescribed varenicline, the researchers found. There were 2,244 cases of depression, but no association was found between varenicline and increased risk of depression, the investigators note. Compared with patients on nicotine replacement products, the hazard ratio for self-harm was 1.12 for those on varenicline and 1.17 for those on bupropion. The limited power of the study meant that a two-fold increased risk of self-harm associated with varenicline cannot be entirely ruled out.
"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," the authors write. "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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