Higher risk of suicidal behaviour association with varenicline: Report

A new study coming out of the Unites States is reporting  that there is a substantial increased risk of reported depression/suicidal behaviour associated with varenicline (Champix) than with other smoking cessation products.  The study looked at 3,249 reported cases of suicidal/self-injurious behaviour, 90% of which was associated with varenicine, 10% with bupropion, and 3% for  [...]

A new study coming out of the Unites States is reporting  that there is a substantial increased risk of reported depression/suicidal behaviour associated with varenicline (Champix) than with other smoking cessation products.  The study looked at 3,249 reported cases of suicidal/self-injurious behaviour, 90% of which was associated with varenicine, 10% with bupropion, and 3% for  other nicotine repalcement.  Although varenicline already carries an FDA black-box warning for the possibility of depression and suicidal thoughts, the investigators of the study are suggesting that these warnings should be modified to specifically state the increased risk compared to other smoking cessation products, and to use this product only when all other treatments have failed.

It should also be noted that the FDA has reportedly dismissed the study, saying that self-reporting of such suicidal behaviours is also linked to media publicity regarding varenicline, something which was not accounted for.  They have however, requested that Champix manufacterer Pfizer conduct a clinical study “to characterize the neuropsychiatric safety profile of varenicline versus placebo, bupropion, and nicotine replacement therapies in subjects with and without a previous history of a psychiatric disorder, with results expected in 2017.”

While these reported results are not necessarily new in regards to varenicline, the possibility of increased risk is definitely something to consider when prescribing such therapy.

Link to article: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0027016