Throughout the world, smoking remains one of the leading preventable causes of illness and premature death. Cigarette smoking is a risk factor for various diseases such as cancer (including lung cancer), chronic obstructive pulmonary disease (COPD), hypertension, coronary heart disease, and cerebrovascular disorders.

Various treatments that help people successfully quit smoking have important effects on health and life expectancy. Medicinal methods must be actively studied and used, but good pharmacovigilance practice must ensure safety. Nicotine replacement therapy (NRT) is quite widespread among medications to support smoking cessation. Despite the many forms of release (chewing gum, sublingual tablets, patches, nasal sprays, inhalers) and the active development of new dosage forms, the effectiveness of NRT does not exceed 6–8%. Another distinguishable method of therapy for tobacco addiction is the use of drugs whose mechanism of action is associated with inhibition of nicotinic acetylcholine receptors (nAChR). Nicotine addiction is caused by the effect of the drug on receptors in the brain that stimulate the release of dopamine. One of the first-line drugs is varenicline.

In contrast to the reaction to nicotine, 40-60% less dopamine is released. Therefore, in people with nicotine addiction, the feeling of comfort is accompanied by no withdrawal symptoms when smoking cessation. When smoking varenicline, no additional increase in dopamine concentration is observed. Therefore, smokers do not experience the pleasure of nicotine and the desire to smoke is reduced.

The drug has been tested in the United States, where good pharmacovigilance practice collects information on adverse events.

In 2009, the US Food and Drug Administration (FDA) issued a warning that the use of varenicline can lead to behavioral changes such as hostility, agitation, depression, suicidal thoughts, and suicidal behavior. As recommended by good pharmacovigilance practice, a risk minimization program was included, which kept the drug on the market and ensured the most favorable benefit / risk ratio.

* T. M. Bukatina, A. S. Kazakov, R. N. Alyautdin, T. V. Romanova, I. I. Snegireva

* T. M. Bukatina, A. S. Kazakov, R. N. Alyautdin, T.V. Romanova, I. I. Snegireva

Federal state budgetary institution “Scientific Center for Expertise of Medicinal Products” Ministry of Health of the Russian Federation, Russian Federation, 127051, Moscow, Petrovsky Boulevard, 8, bldg. 2

* Safety and Risk of Pharmacotherapy 2018.6 (1) .pdf