Is nicotine safe for smoking (tobacco) cessation in pregnant women?

From the Guidelines

Nicotine is not recommended for smoking cessation in pregnant women due to limited evidence on its safety and effectiveness.

Key Points

• The US Preventive Services Task Force (USPSTF) found limited evidence to support the use of nicotine replacement therapy (NRT) for smoking cessation in pregnant women 1.
• While most studies suggested a benefit, no statistically significant increase in cessation was seen, and potential adverse maternal events, such as increased diastolic blood pressure and skin reactions, were reported 1.
• The USPSTF identified no studies on bupropion SR or varenicline pharmacotherapy for tobacco smoking cessation during pregnancy, highlighting the need for more research in this area 1.
• Given the limited evidence, behavioral counseling is currently the recommended approach for smoking cessation in pregnant women.
• It is essential to weigh the potential benefits of NRT against the risks, considering that cigarette smoke contains harmful substances in addition to nicotine, and quitting smoking early in pregnancy can reduce or eliminate adverse effects on fetal growth 1.

From the FDA Drug Label

The harmful effects of cigarette smoking on maternal and fetal health are clearly established. These include low birth weight, an increased risk of spontaneous abortion, and increased perinatal mortality. The specific effects of NICOTROL Inhaler therapy on fetal development are unknown Therefore pregnant smokers should be encouraged to attempt cessation using educational and behavioral interventions before using pharmacological approaches.

NICOTROL Inhaler therapy should be used during pregnancy only if the likelihood of smoking cessation justifies the potential risk of using it by the pregnant patient, who might continue to smoke.

Pregnancy, Warning Tobacco smoke, which has been shown to be harmful to the fetus, contains nicotine, hydrogen cyanide, and carbon monoxide. The NICOTROL Inhaler does not deliver hydrogen cyanide and carbon monoxide. However, nicotine has been shown in animal studies to cause fetal harm. It is therefore presumed that NICOTROL Inhaler can cause fetal harm when administered to a pregnant woman

Nicotine is not established as safe for smoking cessation in pregnant women.

• The effects of nicotine on fetal development are unknown.
• Pregnant smokers should be encouraged to attempt cessation using educational and behavioral interventions before using pharmacological approaches.
• NICOTROL Inhaler therapy should be used during pregnancy only if the likelihood of smoking cessation justifies the potential risk of using it by the pregnant patient, who might continue to smoke 2, 2.

From the Research

Safety of Nicotine for Smoking Cessation in Pregnant Women

• The use of nicotine replacement therapy (NRT) for smoking cessation during pregnancy is a topic of ongoing debate, with some studies suggesting its safety and efficacy 3, 4, while others raise concerns about its potential risks 5, 6.
• Nicotine is classified as a Pregnancy Category D drug, and animal studies have shown that it can adversely affect the developing fetal central nervous system (CNS) 3.
• However, studies of the acute effects of NRT in pregnant humans indicate that nicotine alone has minimal effects on the maternal and fetal cardiovascular systems 3.
• The cumulative abnormalities produced by the various toxins in cigarette smoke are likely responsible for the numerous adverse reproductive outcomes associated with smoking, rather than nicotine itself 3.

Recommendations for NRT Use in Pregnant Women

• Efficacy trials of NRT as adjunctive therapy for smoking cessation during pregnancy should be conducted, with the initial dose of nicotine similar to the dose received from smoking 3.
• Intermittent-use formulations of NRT (gum, spray, inhaler) are preferred over continuous-use formulations (transdermal patch) to minimize the total dose of nicotine delivered to the fetus 3.
• A national registry for NRT use during pregnancy should be created to prospectively collect obstetrical outcome data and determine the safety of NRT use during pregnancy 3.
• Pregnant women with a moderate or high level of addiction may use NRT under the supervision of their physician, while those with a low level of addiction may be advised to use behavioral support instead 5.

Comparison with Other Smoking Cessation Therapeutics

• There is limited data on the safety and efficacy of other smoking cessation therapeutics, such as varenicline and bupropion, during pregnancy, and their use is not recommended until further studies are completed 6.
• Counseling and behavioral support have been shown to be effective in increasing cessation rates among pregnant women, and should be used in conjunction with NRT or other therapeutics 4, 5.