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Smoking cessation: no varenicline

Varenicline is used as a smoking cessation drug. It exposes patients to neuropsychological adverse effects, including depression and suicide, and there is a risk of cardiovascular events in the long term. In practice, it is better to avoid prescribing varenicline as a smoking cessation drug and to keep to nicotine when a drug treatment is deemed necessary.

When varenicline appeared on the market, its harm-benefit balance was no more favourable than that of nicotine.

Since then, there has been increasing evidence of its adverse effects. The drug exposes patients to cardiovascular events in the long term and to neuropsychological adverse effects, including depression and suicide.

An analysis of the US pharmacovigilance data revealed cases of aggressive behaviour and homicidal thoughts attributed to varenicline in patients with no history of psychiatric disorders.

Aggressive actions or thoughts occurred within 3 to 42 days of commencing varenicline treatment, two weeks on average, often preceded by sleep disturbances.

In nearly one case out of three, these manifestations of aggression went hand in hand with suicide or suicidal thoughts. The behaviour of patients who stopped taking varenicline improved. In patients who resumed the treatment, the aggressive behaviour reappeared.

With time, the known adverse effects of varenicline have become increasingly disturbing. If a smoking cessation drug is deemed necessary it is better to keep to nicotine. 

©Prescrire 1 February 2012

"Varenicline: aggression and homicidal ideation" Prescrire Int 2012; 21 (124): 42. (Pdf, subscribers only).

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