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Smoking cessation: no to varenicline

When a smoking cessation drug seems advisable, nicotine is the drug with the best risk-benefit balance.

Smoking causes nearly 5 million deaths a year worldwide, and a quarter to a third of deaths from cancer in Europe.

Drug treatment is only a small part of the battle against smoking, and, when a medical prescription is considered appropriate, nicotine replacement products have the best risk-benefit balance, despite their limited efficacy.

There is fresh evidence of adverse effects of varenicline, which is heavily promoted as a smoking cessation drug. Nearly 1000 reports of severe adverse effects have been registered in the USA, i.e. more than for any other drug during the same period (May 2006 to December 2007): 227 reports of suicidal ideation and behaviour; 525 manifestations of hostility or aggression (suicides, homicidal thoughts, paranoia, hallucinations, etc.); 86 cases of convulsions and 372 cases of motor disorders. 173 reports described injuries as a result of traffic accidents, falls. Cardiac arrest and irregular heartbeat were also reported, together with 338 severe cutaneous disorders and 544 cases of glycaemic disorders. Overall, these numerous adverse effects confirm varenicline’s unfavourable risk-benefit balance.

©Prescrire December 2008

Source: "Arrêt cardiaque et varénicline ?" Rev Prescrire 2008; 28 (301) 836.

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