Nicotine Replacement Therapy in Pregnancy and Major Congenital Anomalies in Offspring

Dhalwani, Nafeesa N.; Szatkowski, Lisa; Coleman, Tim; Fiaschi, Linda; Tata, Laila J.

doi:10.1542/peds.2014-2560

Cited by 42 publications

(57 citation statements)

References 36 publications

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“…Furthermore, one conclusion (Kapur et al 2001) was based on a single case of rapid fetal movements in a subject given a placebo patch, while differences noted in the final study (Pollak et al 2007) were not significant. The only study reporting significantly worse outcomes in smokers using (or allocated to) NRT than in other smokers was the increased incidence of major respiratory system congenital abnormalities (Dhalwani et al 2015) and even here the authors noted “women prescribed NRT were considerably more likely to have diagnosed morbidities, particularly asthma and mental illnesses”. The remaining studies reported finding no effect, some for specific effects and some for a range of effects.…”

Section: Resultsmentioning

confidence: 87%

“…The RRs listed in Table 10 are based on comparison with smokers using NRT, this being non-significant 1.50 (0.94–2.41). A much larger UK study (Dhalwani et al 2015) only reported results for major congenital abnormalities, but found no association with overall risk. Combining the estimate for this study with those for any congenital abnormality in the other studies gave a random-effect estimate of 1.10 (0.86–1.41), which reduced to 1.02 (0.81–1.28) if the result for non-smokers from the Danish cohort was excluded.…”

Section: Resultsmentioning

confidence: 97%

“…A cross-sectional study of women interviewed post-natally (Gaither et al (2009), CAF 8, study quality “fair”) related NRT use in pregnancy to low birthweight and preterm birth of their offspring. Another study (Dhalwani et al (2015), CAF 9, “fair”) used mother–child primary care records of children born in the UK to relate NRT prescription to incidence of major congenital abnormalities. The remainder (Lassen et al (2010); Milidou et al (2012); Morales-Suarez-Varela et al (2006); Strandberg-Larsen et al (2008); Torp-Pedersen et al (2010); Zhu et al (2014), CAFs 2 to 7, all “good”) derived from the Danish National Birth Cohort, each concerning different endpoints.…”

Section: Resultsmentioning

confidence: 99%

“…The large SNAP trial (Cooper et al 2014b) also noted a beneficial effect on development at 2 years. Possible adverse effects were also noted, with the endpoints varying: overall congenital abnormalities (Morales-Suarez-Varela et al 2006); infantile colic (Milidou et al 2012); attention-deficit/hyperactivity disorder (Zhu et al 2014); low birthweight and preterm birth (Gaither et al 2009); respiratory system abnormalities (Dhalwani et al 2015); rapid fetal movements (Kapur et al 2001); and negative birth outcomes (Pollak et al 2007). However, four of these conclusions (Gaither et al 2009; Milidou et al 2012; Morales-Suarez-Varela et al 2006; Zhu et al 2014) were based on significant differences from non-smokers, no longer significant when comparisons were made within smokers.…”

Section: Resultsmentioning

confidence: 99%

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A systematic review of possible serious adverse health effects of nicotine replacement therapy

Fariss

2016

Arch Toxicol

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We conducted a systematic literature review to identify and critically evaluate studies of serious adverse health effects (SAHEs) in humans using nicotine replacement therapy (NRT) products. Serious adverse health effects refer to adverse events, leading to substantial disruption of the ability to conduct normal life functions. Strength of evidence evaluations and conclusions were also determined for the identified SAHEs. We evaluated 34 epidemiological studies and clinical trials, relating NRT use to cancer, reproduction/development, CVD, stroke and/or other SAHEs in patients, and four meta-analyses on effects in healthy populations. The overall evidence suffers from many limitations, the most significant being the short-term exposure (≤12 weeks) and follow-up to NRT product use in most of the studies, the common failure to account for changes in smoking behaviour following NRT use, and the sparse information on SAHEs by type of NRT product used. The only SAHE from NRT exposure we identified was an increase in respiratory congenital abnormalities reported in one study. Limited evidence indicated a lack of effect between NRT exposure and SAHEs for CVD and various reproduction/developmental endpoints. For cancer, stroke and other SAHEs, the evidence was inadequate to demonstrate any association with NRT use. Our conclusions agree with recent statements from authoritative bodies.Electronic supplementary materialThe online version of this article (doi:10.1007/s00204-016-1856-y) contains supplementary material, which is available to authorized users.

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Section: Resultsmentioning

confidence: 87%

Section: Resultsmentioning

confidence: 97%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

A systematic review of possible serious adverse health effects of nicotine replacement therapy

Fariss

2016

Arch Toxicol

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“…NRT is still rarely prescribed during pregnancy, due to concerns over fetal safety. One recent study found similar rates of major congenital anomalies for pregnant women prescribed NRT and those who continued to smoke (35% and 27%, respectively) (67). Findings must be interpreted with caution, however, as confounding factors such as intensity of smoking were not assessed.…”

Section: Pregnant Women: Special Considerationsmentioning

confidence: 98%

Gender Considerations in Addiction: Implications for Treatment

Polak

Haug

Drachenberg³

et al. 2015

Curr Treat Options Psych

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Interventions for Tobacco Cessation in Adults, Including Pregnant Persons

Patnode

Henderson

Coppola

et al. 2021

JAMA

145

132

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ImportanceIt has been estimated that in 2018 nearly 20% of adults in the US were currently using a tobacco product.ObjectiveTo systematically review the effectiveness and safety of pharmacotherapy, behavioral interventions, and electronic cigarettes for tobacco cessation among adults, including pregnant persons, to inform the US Preventive Services Task Force.Data SourcesPubMed, PsycInfo, Database of Abstracts of Reviews of Effects, Cochrane Database of Systematic Reviews, Centre for Reviews and Dissemination of Health Technology Assessment; surveillance through September 25, 2020.Study SelectionSystematic reviews of tobacco cessation interventions and randomized clinical trials that evaluated the effects of electronic cigarettes (e-cigarettes) or pharmacotherapy among pregnant persons.Data Extraction and SynthesisIndependent critical appraisal and data abstraction; qualitative synthesis and random-effects meta-analyses.Main Outcomes and MeasuresHealth outcomes, tobacco cessation at 6 months or more, and adverse events.ResultsSixty-seven reviews addressing pharmacotherapy and behavioral interventions were included as well as 9 trials (N = 3942) addressing e-cigarettes for smoking cessation and 7 trials (N = 2285) of nicotine replacement therapy (NRT) use in pregnancy. Combined pharmacotherapy and behavioral interventions (pooled risk ratio [RR], 1.83 [95% CI, 1.68-1.98]), NRT (RR, 1.55 [95% CI, 1.49-1.61]), bupropion (RR, 1.64 [95% CI, 1.52-1.77]), varenicline (RR, 2.24 [95% CI, 2.06-2.43]), and behavioral interventions such as advice from clinicians (RR, 1.76 [95% CI, 1.58-1.96]) were all associated with increased quit rates compared with minimal support or placebo at 6 months or longer. None of the drugs were associated with serious adverse events. Five trials (n = 3117) reported inconsistent findings on the effectiveness of electronic cigarettes on smoking cessation at 6 to 12 months among smokers when compared with placebo or NRT, and none suggested higher rates of serious adverse events. Among pregnant persons, behavioral interventions were associated with greater smoking cessation during late pregnancy (RR, 1.35 [95% CI, 1.23-1.48]), compared with no intervention. Rates of validated cessation among pregnant women allocated to NRT compared with placebo were not significantly different (pooled RR, 1.11 [95% CI, 0.79-1.56], n = 2033).Conclusions and RelevanceThere is strong evidence that a range of pharmacologic and behavioral interventions, both individually and in combination, are effective in increasing smoking cessation in nonpregnant adults. In pregnancy, behavioral interventions are effective for smoking cessation, but data are limited on the use of pharmacotherapy for smoking cessation. Data on the effectiveness and safety of electronic cigarettes for smoking cessation among adults are also limited and results are inconsistent.

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Nicotine Replacement Therapy in Pregnancy and Major Congenital Anomalies in Offspring

Cited by 42 publications

References 36 publications

A systematic review of possible serious adverse health effects of nicotine replacement therapy

A systematic review of possible serious adverse health effects of nicotine replacement therapy

Gender Considerations in Addiction: Implications for Treatment

Interventions for Tobacco Cessation in Adults, Including Pregnant Persons

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