Safety of Nicotine Replacement Therapy During Pregnancy: A Narrative Review

Background: Smoking during pregnancy is a public health problem worldwide and the leading preventable cause of fetal morbidity and mortality and obstetric disease. Although the risk of tobacco-related harm can be substantially reduced if mothers stop smoking in the first trimester, the proportion of women who do so remains modest; therefore, the treatment of smoking in pregnant women will be the first therapeutic measure that health professionals should adopt when providing care to pregnant women. The recommendation of nicotine replacement therapy during pregnancy remains controversial due to the potential effects on the health of the fetus.

Purpose: The aim of this review was to provide an overview of human studies about the use of nicotine replacement therapy during pregnancy, evaluating the efficacy and safety of the different formulations.

Methods: The electronic databases PubMed and EMBASE were searched from May 2012 to May 2022. A total of 95 articles were identified through database searching using a combination of keywords. Out of 79 screened articles and after the removal of duplicates, 28 full-text articles were assessed for eligibility and 12 articles were finally included for review.

Results: Although demonstrated to be effective in adult smokers, evidence in support of NRT in pregnant women is limited. The results of the apparent safety of the use of NRT during pregnancy contradict the FDA classification of the different NRT formulations. Faster-acting formulations seem to be the safest and even most beneficial forms for the offspring.

Conclusions: NRT is not completely harmless for the fetus or for the mother; however, if an adequate assessment of the risk-benefit binomial is made, its use during pregnancy to aid in quitting smoking does seem appropriate. It is necessary to establish individual recommendations on the formulation and dose to be used during pregnancy based on individual nicotinic needs.