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Pharmacovigilance

Neuropsychiatric review offers reassurance for smokers who quit using varenicline

the largest review of clinical trials to date has found no evidence of an increased risk of suicide or attempted suicide, suicidal ideation, depression or death in people taking the smoking cessation drug varenicline (Champix)

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The largest review of clinical trials to date has found no evidence of an increased risk of suicide or attempted suicide, suicidal ideation, depression or death in people taking the smoking cessation drug varenicline (Champix)

The smoking cessation drug varenicline (Champix) is known to be associated with an increased risk of certain neuropsychiatric effects, such as sleep disorders. Regulatory agencies in the UK and United States have also issued warnings regarding suicidal thoughts and depression associated with varenicline, based on reports from spontaneous reporting systems.

Now, the largest review of clinical trials to date has found no evidence of an increased risk of suicide or attempted suicide, suicidal ideation, depression or death in people taking varenicline. The meta-analysis of 39 trials involving 10,761 patients found that varenicline was associated with an increased risk of sleep disorders, insomnia, abnormal dreams and fatigue, but a reduced risk of anxiety.

The study provides “some reassurance” for users and prescribers, say the authors in The BMJ[1] (online, 12 March 2015).

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20068232

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