Effect of nicotine patches in pregnancy on infant and maternal outcomes at 2 years: follow-up from the randomised, double-blind, placebo-controlled SNAP trial

Cooper, Sue; Taggar, Jaspal; Lewis, Sarah; Marlow, Neil; Dickinson, Anne; Whitemore, Rachel; Coleman, Tim

doi:10.1016/s2213-2600(14)70157-2

Cited by 67 publications

(64 citation statements)

References 29 publications

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“…Possible beneficial effects were concluded for three trials (El-Mohandes et al 2013; Oncken et al 2008; Wisborg et al 2000) based on increases in birthweight and/or gestational age in the NRT group. 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).…”

Section: Resultsmentioning

confidence: 97%

“…The longest was the 7½-year follow-up for cancer of participants in the Lung Health Study (Murray et al 2009) and the follow-up until 2011 for investigating attention-deficit/hyperactivity disorder (ADHD) of children born between 1996 and 2003 in the Danish National Birth Cohort study (Zhu et al 2014). A follow-up until 2006 for investigating strabismus in the same study (Torp-Pedersen et al 2010) and two-year follow-ups in two clinical trials (Cooper et al 2014b; Mohiuddin et al 2007) were the only other studies appearing to involve more than one year of follow-up.…”

Section: Resultsmentioning

confidence: 99%

“…Two (CAFs 13, 15) concern a multicentre trial in North Carolina (risk of bias “unclear”), one (Pollak et al 2007) reporting results for various endpoints, the other (Swamy et al 2009) presenting a detailed analysis of adverse events following medical record review. Three (CAFs 16, 19 and 20) concern a multicentre trial in England (risk of bias “low”), Coleman et al (2012b) giving results for various endpoints recorded at or before birth, Cooper et al (2014b) reporting on infant and maternal outcomes at 2 years, and Cooper et al (2014a) presenting an extremely detailed report, but providing no additional relevant results. This is by far the largest study.…”

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: 97%

Section: Resultsmentioning

confidence: 99%

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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“…Based on a metaanalysis of these trials, smoking cessation rates late in pregnancy were not significantly improved with NRT (10.8%) compared to placebo (8.5%), RR:1.24 (CI 0.95-1.64) [49]. There is some evidence from smaller trials that NRT use is safe and can show benefit in development for up to 2 years [50][51]; however, additional trials are warranted to confirm these findings.…”

Section: Pregnancymentioning

confidence: 97%

An update on the pharmacotherapeutic interventions for smoking cessation

Barboza

Patel

et al. 2016

Expert Opinion on Pharmacotherapy

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“…Lastly, a recent Cochrane review suggests that use of medicinal nicotine by pregnant women who smoke has no negative effects on birth outcomes [57]. A randomized trial of use of nicotine during pregnancy showed that children born to smokers who used pharmaceutical nicotine products during pregnancy were more likely to have better developmental outcomes than children of smokers who received a placebo [58]. All of these findings support the premise that the adverse outcomes are most likely due to other toxicants carried in tobacco smoke, not to the nicotine.…”

Section: Effects Of Nicotine Inhalation By the E-cigarette Usermentioning

confidence: 99%

A critique of the US Surgeon General’s conclusions regarding e-cigarette use among youth and young adults in the United States of America

Polosa

Russell²,

Nitzkin³

et al. 2017

Harm Reduct J

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Background: In December 2016, the Surgeon General published a report that concluded e-cigarette use among youth and young adults is becoming a major public health concern in the United States of America. Methods: Re-analysis of key data sources on nicotine toxicity and prevalence of youth use of e-cigarettes cited in the Surgeon General report as the basis for its conclusions. Results: Multiple years of nationally representative surveys indicate the majority of e-cigarette use among US youth is either infrequent or experimental, and negligible among never-smoking youth. The majority of the very small proportion of US youth who use e-cigarettes on a regular basis, consume nicotine-free products. The sharpest declines in US youth smoking rates have occurred as e-cigarettes have become increasingly available. Most of the evidence presented in the Surgeon General's discussion of nicotine harm is not applicable to e-cigarette use, because it relies almost exclusively on exposure to nicotine in the cigarette smoke and not to nicotine present in ecigarette aerosol emissions. Moreover, the referenced literature describes effects in adults, not youth, and in animal models that have little relevance to real-world e-cigarette use by youth. The Surgeon General's report is an excellent reference document for the adverse outcomes due to nicotine in combination with several other toxicants present in tobacco smoke, but fails to address the risks of nicotine decoupled from tobacco smoke constituents. The report exaggerates the toxicity of propylene glycol (PG) and vegetable glycerin (VG) by focusing on experimental conditions that do not reflect use in the real-world and provides little discussion of emerging evidence that e-cigarettes may significantly reduce harm to smokers who have completely switched. Conclusions: The U.S. Surgeon General's claim that e-cigarette use among U.S. youth and young adults is an emerging public health concern does not appear to be supported by the best available evidence on the health risks of nicotine use and population survey data on prevalence of frequent e-cigarette use. Nonetheless, patterns of e-cigarettes use in youth must be constantly monitored for early detection of significant changes. The next US Surgeon General should consider the possibility that future generations of young Americans will be less likely to start smoking tobacco because of, not in spite of, the availability of e-cigarettes.

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Effect of nicotine patches in pregnancy on infant and maternal outcomes at 2 years: follow-up from the randomised, double-blind, placebo-controlled SNAP trial

Abstract: National Institute for Health Research Health Technology Assessment Programme.

Cited by 67 publications

References 29 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

An update on the pharmacotherapeutic interventions for smoking cessation

A critique of the US Surgeon General’s conclusions regarding e-cigarette use among youth and young adults in the United States of America

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