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Nicotine Tob Res. 2009 Nov;11(11):1265-73. doi: 10.1093/ntr/ntp136. Epub 2009 Aug 28.

What do we know about the role of pharmacotherapy for smoking cessation before or during pregnancy?

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  • 1Department of Medicine, MC 3940, University of Connecticut School of Medicine, 263 Farmington Avenue, Farmington, CT 06030-3940, USA.



Given the substantial health risks of smoking during pregnancy, and the potential of pharmacotherapy to enhance quit rates, a need exists to examine the utility of pharmacotherapy for smoking cessation during pregnancy.


We briefly review the first-line medications that are recommended for smoking cessation in nonpregnant adults. Additionally, we review the toxicity of tobacco smoke and the potential risks of pharmacotherapy as evidenced by animal studies. We review in more detail studies conducted in pregnant women, including (a) observational studies, (b) short-term safety and longer term uncontrolled studies, and (c) randomized controlled clinical trials (both effectiveness and efficacy studies).


Because the safety and efficacy of pharmacotherapy for smoking cessation during pregnancy have not been established, no definitive recommendations can be made on the topic. Effectiveness trials have shown that nicotine replacement therapy (NRT) enhances smoking cessation during pregnancy, but efficacy trials have not shown an advantage for NRT compared with placebo treatment. Small sample size or poor medication compliance (with either the dose or the duration of treatment) may contribute to lack of efficacy in placebo-controlled NRT trials. However, these trials showed that NRT did not adversely affect birth outcomes and increased birth weight. Based on these findings and the fact that all medications have some risk, psychosocial interventions should be the first treatment option for pregnant smokers. Additional research is needed to determine fully the risks and benefits of the various pharmacotherapies for smoking cessation during pregnancy.

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