english.prescrire.org > Spotlight > Archives : 2014 > Smoking cessation: varenicline has too many adverse effects to be used or... reused

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Smoking cessation: varenicline has too many adverse effects to be used or... reused

Varenicline is authorised as a smoking cessation treatment despite its unfavourable harm-benefit balance. Regrettably, this authorisation has now been extended, encouraging varenicline to be reused after the failure of an initial course.

Varenicline is used as a tobacco cessation drug. It has an unfavourable harm-benefit balance: its efficacy is both limited and temporary, and the drug can cause severe, potentially fatal, adverse effects: depression, suicide, severe allergy, myocardial infarction, cardiac arrhythmia.

In late 2013, on the recommendation of the European Medicines Agency, the European Commission agreed to extend the use of varenicline, explicitly encouraging it to be reused after the failure of an initial course.

That decision was based on the results of a trial comparing varenicline to a placebo. The trial, which shows that varenicline has only a limited effect, does not justify repeated exposure to the drug’s adverse effects.

In practice, when a medication is sought to assist smoking cessation, nicotine is the drug that is in patients’ best interests: its efficacy is also limited, with a success rate of around 16% after one year, but its adverse effects are acceptable, unlike those of varenicline.

©Prescrire 1 September 2014

"Smoking cessation and varenicline. Do not expose or re-expose patients to its serious adverse effects!" Prescrire Int 2014; 23 (152): 207. (Pdf, subscribers only).
Download the full review.
Pdf, subscribers only

See also:

Repeating the same
mistake
Prescrire Int 2014;
23 (152): 200.
Pdf, free
 
Smoking cessation:
no varenicline
(February 2012)
Free