Neonatal Abstinence Syndrome after Methadone or Buprenorphine Exposure

Jones, Hendrée E.; Kaltenbach, Karol; Heil, Sarah H.; Stine, Susan M.; Coyle, Mara G.; Arria, Amelia M.; O’Grady, Kevin E.; Selby, Peter; Martin, Peter; Fischer, Gabriele

doi:10.1056/nejmoa1005359

Cited by 846 publications

(847 citation statements)

References 42 publications

(37 reference statements)

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“…Of 1111 citations identified, 140 full‐text papers were assessed for eligibility, and 18 studies 18, 19, 20, 21, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49 (reported in 23 papers 18, 19, 20, 21, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52) satisfied our inclusion criteria (Fig. 1).…”

Section: Resultsmentioning

confidence: 99%

“…EGA = estimated gestational age.aWe included one study that treated women with an abuse‐deterrent combination buprenorphine (BUP)–naloxone formulation 44, but excluded it from quantitative analyses.bPreterm birth was defined as < 36 completed weeks gestation in Colombini 2008 37.cSGA was defined as birth weight below: (a) 2 standard deviations from the sex‐ and gestational‐week specific mean value (Jones 2010 19; Kakko 2008 39); (b) 10th percentile of the sex‐ and gestational‐week specific mean value (Siedentopf 2004 47); or (c) the 5th percentile of the sex‐ and gestational‐week specific mean value (Brulet 2007 36; Meyer 2015 43). …”

Section: Methodsmentioning

confidence: 99%

“…SGA was defined as birth weight below: (a) 2 standard deviations from the sex‐ and gestational‐week specific mean value (Jones 2010 19; Kakko 2008 39); (b) 10th percentile of the sex‐ and gestational‐week specific mean value (Siedentopf 2004 47); or (c) the 5th percentile of the sex‐ and gestational‐week specific mean value (Brulet 2007 36; Meyer 2015 43). …”

Section: Methodsmentioning

confidence: 99%

“…Maternal adverse events were defined as: (a) medical events (Lacroix 2011 41); (b) complications (Prasad 2013 44); or (c) any untoward medical occurrence (Jones 2010 19). …”

Section: Methodsmentioning

confidence: 99%

“…We anticipated a substantial amount of missing outcome data from attrition based upon the challenges of research with opioid‐dependent people, especially during pregnancy 19, 28, 29. We decided a priori to include only unadjusted outcome data as available from studies with low or medium ROB in our main analyses.…”

Section: Methodsmentioning

confidence: 99%

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Buprenorphine compared with methadone to treat pregnant women with opioid use disorder: a systematic review and meta‐analysis of safety in the mother, fetus and child

et al. 2016

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AimsTo assess the safety of buprenorphine compared with methadone to treat pregnant women with opioid use disorder.MethodsWe searched PubMed, Embase and the Cochrane Library from inception to February 2015 for randomized controlled trials (RCT) and observational cohort studies (OBS) that compared buprenorphine with methadone for treating opioid‐dependent pregnant women. Two reviewers assessed independently the titles and abstracts of all search results and full texts of potentially eligible studies reporting original data for maternal/fetal/infant death, preterm birth, fetal growth outcomes, fetal/congenital anomalies, fetal/child neurodevelopment and/or maternal adverse events. We ascertained each study's risk of bias using validated instruments and assessed the strength of evidence for each outcome using established methods. We computed effect sizes using random‐effects models for each outcome with two or more studies.ResultsThree RCTs (n = 223) and 15 cohort OBSs (n = 1923) met inclusion criteria. In meta‐analyses using unadjusted data and methadone as comparator, buprenorphine was associated with lower risk of preterm birth [RCT risk ratio (RR) = 0.40, 95% confidence interval (CI) = 0.18, 0.91; OBS RR = 0.67, 95% CI = 0.50, 0.90], greater birth weight [RCT weighted mean difference (WMD) = 277 g, 95% CI = 104, 450; OBS WMD = 265 g, 95% CI = 196, 335] and larger head circumference [RCT WMD = 0.90 cm, 95% CI = 0.14, 1.66; OBS WMD = 0.68 cm, 95% CI = 0.41, 0.94]. No treatment differences were observed for spontaneous fetal death, fetal/congenital anomalies and other fetal growth measures, although the power to detect such differences may be inadequate due to small sample sizes.ConclusionsModerately strong evidence indicates lower risk of preterm birth, greater birth weight and larger head circumference with buprenorphine treatment of maternal opioid use disorder during pregnancy compared with methadone treatment, and no greater harms.

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Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

“…Maternal adverse events were defined as: (a) medical events (Lacroix 2011 41); (b) complications (Prasad 2013 44); or (c) any untoward medical occurrence (Jones 2010 19). …”

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Buprenorphine compared with methadone to treat pregnant women with opioid use disorder: a systematic review and meta‐analysis of safety in the mother, fetus and child

et al. 2016

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Neonatal Abstinence Syndrome and Associated Health Care Expenditures

Patrick

Schumacher

Benneyworth

et al. 2012

JAMA

843

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RECENT NATIONAL STUDY indicated that illicit drug use is 16.2% among pregnant teens and 7.4% among pregnant women aged 18 to 25 years. 1 Neonatal abstinence syndrome (NAS) is a drug withdrawal syndrome in newborns following birth. The syndrome most commonly occurs in the context of antepartum opiate use, although other drugs have also been implicated. [2][3][4][5] In addition to NAS, illicit drug use (specifically opioid dependence) during pregnancy is associated with a significantly increased risk of adverse neonatal outcomes such as low birthweight (Ͻ2500 g) and mortality. [6][7][8][9] Neonatal abstinence syndrome is characterized by a wide array of signs and symptoms including increased irritability, hypertonia, tremors, feeding intolerance, emesis, watery stools, seizures, and respiratory distress. 10 Symptoms of withdrawal associated with NAS have been described in 60% to 80% of newborns exposed to heroin or methadone in utero. 11 Recently, analyses from Australia 12 and the Florida Medicaid program (D. Aronberg, JD, written communication, November 30, 2011) found that the incidence of NAS has been increasing. To date, there are no national es-Author Affiliations are listed at the end of this article.

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