Pregnancy outcomes after maternal varenicline use; analysis of surveillance data collected by the European Network of Teratology Information Services

Richardson, Jonathan L.; Stephens, Sally; Yates, Laura; Diav–Citrin, Orna; Arnon, Judy; Beghin, Delphine; Kayser, Angela; Kennedy, Debra; Cupitt, D.; Winkel, Bernke te; Peltonen, M.; Kaplan, Yusuf Cem; Thomas, Simon H.L.

doi:10.1016/j.reprotox.2016.11.010

Cited by 24 publications

(26 citation statements)

References 20 publications

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“…Included studies comprised two randomised controlled trials (RCTs) 22,23 , eleven cohort studies [24][25][26][27][28][29][30][31][32][33][34] , two case-control studies 35,36 , and three case reports. [37][38][39] Maternal or foetal adverse outcomes were reported in fourteen bupropion [22][23][24][25][26][27][28][29][30][31][36][37][38] and four varenicline studies.…”

Section: Study Design Outcome Measures and Quality Assessmentmentioning

confidence: 99%

“…[37][38][39] Maternal or foetal adverse outcomes were reported in fourteen bupropion [22][23][24][25][26][27][28][29][30][31][36][37][38] and four varenicline studies. [32][33][34]39 Although bupropion can be used as an anti-depressant or for smoking cessation, only two RCTs specified that bupropion had been prescribed for smoking cessation. 22,23 The three observational studies evaluating varenicline exposure did not explicitly state that varenicline was used for smoking cessation, but all discussed its sole indication as a cessation pharmacotherapy.…”

Section: Study Design Outcome Measures and Quality Assessmentmentioning

confidence: 99%

“…22,23 The three observational studies evaluating varenicline exposure did not explicitly state that varenicline was used for smoking cessation, but all discussed its sole indication as a cessation pharmacotherapy. [32][33][34] Congenital malformations were reported in eight studies (six following bupropion [27][28][29][30]35,36 and two following varenicline 33,34 ); reported malformation classification systems are described in Supplementary Material Table 1. Birthweight and gestational age at delivery were reported in five bupropion studies [22][23][24]26,27 .…”

Section: Study Design Outcome Measures and Quality Assessmentmentioning

confidence: 99%

“…Birthweight and gestational age at delivery were reported in five bupropion studies [22][23][24]26,27 . Other outcomes included: foetal loss or stillbirth 25,27,30,32,34 ; foetal length or head circumference 22,23 ; preterm birth [22][23][24] ; maternal medication adverse effects 23,25,39 ; and pre-eclampsia. 31 An overview of reported outcomes is shown in Table 1.…”

Section: Study Design Outcome Measures and Quality Assessmentmentioning

confidence: 99%

“…31 An overview of reported outcomes is shown in Table 1. Table 2) with seven of the eleven observational studies assessed as of low methodological quality (score of <7) 25,26,29,30,[32][33][34] ; the three case reports were considered to provide only low-quality evidence. [37][38][39]…”

Section: Study Design Outcome Measures and Quality Assessmentmentioning

confidence: 99%

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Systematic Review and Meta-Analysis to Assess the Safety of Bupropion and Varenicline in Pregnancy

Turner

Jones

Vaz

et al. 2018

Nicotine &Amp; Tobacco Research

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We believe this to be the first systematic review investigating the safety of bupropion and varenicline in pregnancy. Meta-analysis of outcomes following bupropion exposure in pregnancy suggests that there are no major positive or negative impacts on the rate of congenital abnormalities, birthweight or premature birth. Overall, we found no evidence that either of these treatments might be harmful in pregnancy, and no strong evidence to suggest safety, but available evidence is of poor quality.

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Section: Study Design Outcome Measures and Quality Assessmentmentioning

confidence: 99%

Section: Study Design Outcome Measures and Quality Assessmentmentioning

confidence: 99%

Section: Study Design Outcome Measures and Quality Assessmentmentioning

confidence: 99%

Section: Study Design Outcome Measures and Quality Assessmentmentioning

confidence: 99%

Section: Study Design Outcome Measures and Quality Assessmentmentioning

confidence: 99%

See 3 more Smart Citations

Systematic Review and Meta-Analysis to Assess the Safety of Bupropion and Varenicline in Pregnancy

Turner

Jones

Vaz

et al. 2018

Nicotine &Amp; Tobacco Research

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Risk of adverse birth outcomes after maternal varenicline use: A population‐based observational study in Denmark and Sweden

Pedersen

Petronis

Nørgaard

et al. 2019

Pharmacoepidemiology and Drug

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Purpose: To examine risks of adverse birth outcomes in women exposed to varenicline during pregnancy.Methods: Population-based cohort study including live-born and stillborn infants from 1 May 2007 to 31 December 2012. Data from health and administrative registries in Denmark and Sweden, two Nordic countries with universal health care and routine registration of major life and health events. Infants were allocated to three cohorts on the basis of their in utero exposure: the exposed cohort consisting of infants whose mothers were dispensed varenicline during pregnancy; the unexposed cohort comprised infants unexposed to varenicline, but exposed to maternal smoking in utero; and the reference cohort of infants unexposed to varenicline and maternal smoking in utero.The primary outcome was major congenital malformations diagnosed from birth to the first year of life. Secondary outcomes included stillbirth, fetal growth restriction (measured as small for gestational age), preterm delivery, preterm premature rupture of membranes, and sudden infant death syndrome. We estimated the prevalence of the primary outcome and secondary outcomes in the exposed, unexposed, and reference cohorts. Prevalence odds ratios with 95% confidence intervals (CIs) were computed using logistic regression with propensity score adjustment to control for potential confounders. Results:The combined cohort included 885 185 infants. Of these, 335 infants were exposed, 78 412 were unexposed, and the remaining 806 438 comprised the reference cohort. Major congenital malformations were detected among 3.6% of exposed infants, 4.3% of unexposed infants, and 4.2% of infants in the reference cohort. The propensity score-adjusted prevalence odds ratio for major congenital malformations was 0.80 (95% CI, 0.45-1.42) for exposed vs unexposed infants. All analyses of primary and secondary outcomes comparing exposed with unexposed infants yielded odds ratio estimates below or close to unity.Use of varenicline during pregnancy does not appear to increase the risk of major congenital malformations or other adverse birth outcomes. KEYWORDSobservational study, pharmacoepidemiology, pregnancy outcome, vareniclineMaternal smoking is associated with a wide range of adverse pregnancy outcomes, such as placental complications, preterm birth, and fetal death. 1 Whether smoking during pregnancy increases the prevalence of congenital malformations remains unsettled; the existing literature shows no strong teratogenic effect on congenital malformations overall. 2,3 But smoking may increase the risk of specific malformations such as cardiovascular defects and oral clefts. 3,4 Smoking cessation programs should always be offered to smokers who plan a pregnancy, but the safety of nicotine substitute use in pregnancy is unknown. 5 One previous study found that nicotine replacement therapy was associated with increased risk of congenital malformations in children born to nonsmoking mothers, 6 while several other studies found no association with risk of stillbirth or low birthw...

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Maternal Use of Other Psychoactive Drugs and Infant Congenital Malformations

Källén

2019

Maternal Drug Use and Infant Congenital Malformations

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Pregnancy outcomes after maternal varenicline use; analysis of surveillance data collected by the European Network of Teratology Information Services

Cited by 24 publications

References 20 publications

Systematic Review and Meta-Analysis to Assess the Safety of Bupropion and Varenicline in Pregnancy

Systematic Review and Meta-Analysis to Assess the Safety of Bupropion and Varenicline in Pregnancy

Risk of adverse birth outcomes after maternal varenicline use: A population‐based observational study in Denmark and Sweden

Maternal Use of Other Psychoactive Drugs and Infant Congenital Malformations

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