Nicotine-Replacement Therapy Needs More Study as an Aid to Helping Pregnant Smokers Quit

Background papers on the use of nicotine and other smoking cessation medications in pregnant and adolescent smokers

From 1998 to 1999, researchers at the University of California, San Francisco, School of Medicine prepared a background paper on the risks and benefits of using nicotine replacement therapies and other smoking-cessation aids approved by the Food and Drug Administration (FDA) to treat pregnant smokers.

There is growing evidence that these smoking cessation aids can double the usual smoking quit rates achieved through self-help programs.

This project consisted of a literature review and critical analysis of the potential risks and benefits of using FDA-approved pharmacological quitting aids, including reviews of published and pre-publication research reports and FDA materials.

Key Results

  • The paper, entitled Risks and Benefits of Nicotine and Other Medications to Aid Smoking Cessation in Pregnancy, focused on smoking cessation during pregnancy and lactation. Among the issues examined were:
    • The adverse effects of cigarette smoking on reproduction.
    • The risks and benefits of nicotine replacement and other pharmacologic therapies to aid smoking cessation.
    • Recommendations for targeting groups of pregnant women who should be offered nicotine replacement or other pharmacologic therapy to help quit smoking.

    The report's conclusions on the effects of smoking during pregnancy were:
    • Cigarette smoking during pregnancy is a major cause of injury to mother and newborn.
    • Cigarette smoke contains thousands of chemicals, many of which are likely to contribute to reproductive problems.
    • Carbon monoxide and nicotine are the best studied of the reproductive toxins present in tobacco smoke.
    • Extensive studies in animals have shown that exposure to carbon monoxide in utero reduces body and brain weight, disrupts brain structure and function, and leads to behavioral abnormalities in newborn animals.
    • Nicotine is potentially neurotoxic to the developing fetal brain, resulting in impaired brain development and behavioral disturbances in newborn animals.
    • Further research is needed on the nature and mechanisms of reproductive toxicity of nicotine and other chemicals in tobacco smoke — studied both individually and in combination in animals.

    With regard to nicotine replacement therapy and other medications to aid smoking cessation during pregnancy, the researchers concluded that:
    • Because cigarette smoking is so toxic, and this toxicity is due to a number of chemicals in addition to nicotine, the benefits of prescribing nicotine replacement medications to aid smoking cessation in pregnancy are likely to outweigh the risks of the medication.
    • The efficacy of nicotine replacement therapy as an aid to smoking cessation in pregnancy has not been demonstrated, and this should be done in randomized clinical trials with careful monitoring and reporting of possible adverse events.
    • Physicians in the community are currently using nicotine replacement medications with their pregnant patients. The researchers recommend that a birth registry be set up to collect data on the safety of nicotine used during pregnancy.
    • Inadequate information is available to make recommendations on the risks versus benefits of other medications to aid smoking cessation during pregnancy.
  • The paper was presented at a May 1999 conference on the "Use of Pharmacotherapies for Smoking Cessation during Pregnancy," sponsored by the RWJF national program Smoke-Free Families and the National Institute of Child Health and Human Development.

    The paper was also accepted for publication in Drug Safety and sent to the FDA and several researchers in the field.

A similar background paper on treating adolescent smokers, which had been planned as part of the grant, was not prepared because the first paper took longer than anticipated.


The Robert Wood Johnson Foundation (RWJF) supported the project with a grant of $44,449 between August 1998 and February 1999.