Children and Adolescents
It’s true that nicotine replacements have been shown to be safe for use by adolescents, but there’s very little evidence to show that these, as well as Buproprion SR are of any use in helping adolescent smokers quit. Therefore, they’re not recommended as a component in adolescent smokers’ cessation methods.
Behavioral therapy is always a first-line intervention with pregnant women who smoke.
Non-pharmacologic intervention is most preferred in pregnancy. Utah’s Quit Line has special resources for women who are pregnant, including five free customized counseling sessions with the same cessation counselor, interpretation provided for any non-English languages, timing to support cessation in pregnancy and post-partum support.
If a patient has not succeeded with cessation therapy or is at high risk to fail non-pharmacologic intervention alone, smokes >10 cigarettes daily, nicotine replacement therapy is an option. It is suggested that five questions be considered by the physician when making the recommendation of NRT to a pregnant patient (B. K. Chan 2003):
- Has the patient been provided “Best Practice” (e.g. videos, information packages) methods yet and did not quit?
- Has the patient reported smoking more than 10 cigarettes per day?
- Does the patient smoke her first cigarette within the first 60 minutes of getting up?
- Has the patient indicated that she wants to quit?
- Is the fetus’s gestational age less than 20 weeks?
Pharmacological Treatment Options
Nicotine Replacement Patches
- Clinical trials evaluating the safety and efficacy of nicotine patches by pregnant women have yielded mixed results, and so evidence is currently inconclusive (Coleman, Cochrane 2012).
- It is suggested that there may be higher efficacy with higher-dose patches, but more study is needed.
- A recent clinical trial (Coleman, NEJM 2012) has found that use of the patch during pregnancy did not show an increased rate of abstinence or adverse pregnancy/birth outcomes (however, 90 percent of patients were non-adherent with using the patch).
- A meta-analysis (Coleman 2011) was inconclusive regarding safety and efficacy. This study observed a trend of improved birth outcomes, but this was statistically insignificant.
- A study of combination NRT (Brose 2013) — the patch plus a fast-acting form such as gum or inhaler — showed a significantly increased quit rate for the combination approach in pregnant smokers in comparison to the patch alone.
- Nicotine patches need to be used in conjunction with behavioral modification therapy.
- Nicotine patches are not recommended for patients who smoke five or fewer cigarettes daily.
- Due to increased metabolism, higher doses of nicotine patches are likely necessary in pregnancy (21 mg vs. 14 mg).
- According to the GlaxoSmithKline Prospective Registry (GSK, 2008), women who were exposed to bupropion in either the first or second trimester were followed and no pattern of major birth defects were found.
- A small study (Chan et al 2005) of 136 women found no increased risk for birth defects in women who used bupropion in the first trimester.
- Based on limited information and no conclusive human studies, there is probably not an increased risk of birth defects with exposure to bupropion during pregnancy.
- There are no RCTs of efficacy of bupropion for smoking cessation in pregnancy.
- There are no human control trials of use during pregnancy or lactation.
- One case report (Kaplan 2014) of a woman with an unplanned pregnancy who used varenicline for four weeks from last menstrual period delivered a full-term infant; no pregnancy/birth complications noted.
- Prospective cohort study (Harrison-Woolrych 2013) described 23 cases of pregnancies where varenicline was used from time of conception; study was too small to draw any conclusions.
- Based on limited information and no useful studies in humans, the potential for an increased risk of birth defects with exposure to varenicline is unknown.
Breast Feeding Women
Post-partum maintenance of cessation and assistance with initiation of cessation can safely be supported with pharmacologic therapies (see below) in cases where behavioral therapies are not successful and the patient is determined to quit. The patient must partner with her medical provider for safe cessation. Link here for behavioral best practices as well as links to the Utah Quit Line which provides free behavioral support therapy for lactating women.
Nicotine Replacement Patches
- While using a 21 mg transdermal patch, the amount of nicotine that passes into breast milk is equivalent to smoking 17 cigarettes daily.
- Breastfeeding nicotine levels were lower in breast milk in women who used a 7 or 14 mg/day patch versus women who continued to smoke while breast-feeding.
- Based on animal data, nicotine may increase the risk of sudden infant death syndrome and might even interfere with normal infant lung development.
- In a study of the infants of five mothers who were using 21mg nicotine patches for smoking cessation, the infants’ average Denver Developmental age was equivalent to their chronological age.
- In a study of 15 nursing mothers who were using nicotine patches in decreasing doses from 21 mg to 14 mg to 7 mg over several weeks, their average milk production was 17 percent lower than average literature values of nonsmoking mothers. In this study, infant milk intake during maternal use of the nicotine patch was similar to that during smoking.
- Other chemicals and toxins present in cigarette smoke have not been studied for effect on breast milk and the breastfeeding mother. However, these other chemicals are absent from nicotine patches.
Nicotine Spray or Gum
- No studies on nicotine spray or nicotine gum use in nursing mothers have been reported.
- Maternal plasma nicotine concentrations after using the nicotine spray are about one-third those of smokers, so milk concentrations are probably proportionately less.
- Four small studies evaluated bupropion levels in breast milk in women.
- There is low transfer of bupropion and its metabolites in breast milk.
- Bupropion is undetectable in plasma of breastfed infants.
- Based on limited human information, bupropion passes into the breast milk and probably does not have an adverse effect on the breastfed infant.
Varenicline — NOT RECOMMENDED
- No human studies have been done on the safety of varenicline in pregnancy or lactation. It is unknown whether varenicline passes into breast milk. The effect on the infant is not known.
Psychiatric Disorders, Including Substance Abuse
Of course smokers with psychiatric disorders, including those with substance abuse disorders should be offered treatment for their tobacco dependence just like any other patient. Tobacco dependence among this group is complicated by the varied diagnoses that fall under this category as well as the numerous medications used to treat their conditions–tobacco cessation can affect the functionality of certain psychiatric medications. However, clinicians should overcome their reluctance to treat this population for tobacco dependence while carefully monitoring the affects their patients experience.
Resources: Pregnant Women & Breast Feeding Women
Baab SW, Peindl KS, Piontek CM, Wisner KL. Serum bupropion levels in two breastfeeding mother-infant pairs. J Clin Psychiatry. 2002; 63(10): 910-11.
Briggs G, et al. Excretion of bupropion in breast milk. Ann Pharmacother. 1993; 27(4): 431-433.
Davis MF, Miller HS, Nolan PE. Bupropion levels in breast milk for four mother-infant pairs: more answers to lingering questions. J Clin Psychiatry. 2009; 70(2):297-8.
Einarson A, Riordan S. Smoking in pregnancy and lactation: a review of risks and cessation strategies. Eur J Clin Pharmacol. 2009; 65(4): 325-40.
Haas J, Kaplan C, Barenboim D, Jacob P, Benowitz N. Bupropion in breast milk: an exposure assessment for potential treatment to prevent post-partum tobacco use. Tob Control. 2004; 13(1): 52–6.
Schatz BS. Nicotine replacement products: implications for the breastfeeding mother. J Human Lact. 1998; 14(2): 161-3.
U.S. National Library of Medicine. LactMed. October 22, 2013. Available at: http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f?./temp/~PWzvJX:1. Accessibility verified May 5, 2014.