October 2, 2009

New Chantix study shows no direct link to suicide

Despite recent FDA warnings and adverse event reportings about Chantix (varenicline), a new study reported online in the British Medical Journal has found no direct link between Chantix and increased suicide risks. The researchers conducted a cohort study between 2006-2008 of over 80,000 patients aged 16 to 95 who were prescribed a new course of any smoking cessation product such as Chantix, Zyban, or nicotine replacement products. There were 166 cases of non-fatal self-harm, two suicides (both in nicotine replacement group), and 37 episodes of suicidal thoughts. Researchers said the incidence of self-harm was 533.1 per 100,000 person years in patients on Chantix, 498.7 for those on Zyban, and 751.7 for those patients on nicotine replacement products. Researchers found "no clear evidence" that Chantix was associated with an increased risk or suicide, but they could not rule out a two-fold increased risk "on the basis of the upper limit of the 95% confidence interval". Chantix was also associated with a 43% increased risk of suicidal thoughts compared with nicotine replacement products. Researchers cautioned that the study may have been limited in its power since suicidal thoughts are under-recorded in the General Practice Research Database from which they gathered the data.


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