Neonatal outcomes following in utero exposure to buprenorphine/naloxone or methadone

Abstract

Objectives:To study neonatal outcomes following buprenorphine/naloxone and methadone exposure during pregnancy.Methods:This study is a retrospective review of clinical and demographic information of 58 infants whose mothers were treated with buprenorphine/naloxone and 92 infants whose mothers were treated with methadone for opioid dependence during pregnancy.Results:Gestational age, birth weight, prematurity, admission to neonatal intensive care unit, and length of stay were similar between both groups of infants. Neonatal abstinence syndrome occurred less frequently among infants of mothers treated with buprenorphine/naloxone than those treated with methadone (64% and 80%, respectively, p = 0.03). All infants with neonatal abstinence syndrome were treated postnatally with methadone. There was a trend toward shorter duration of treatment and lower cumulative dosages of methadone among the buprenorphine/naloxone–exposed infants.Conclusions:No apparent significant adverse neonatal outcomes were detected following treatment with either maintenance medication; however, further prospective research is necessary to examine the safety and efficacy of buprenorphine/naloxone in pregnancy and its effects on the neonate.

Buprenorphine-naloxone use in pregnancy: a systematic review and metaanalysis

“…The NICU admission rates of neonates exposed to other forms of MAT ranged from 20% to 39%, which, on a study-bystudy basis, were not significantly different. 20,21,23 Four study groups compared the need for treatment of neonatal abstinence syndrome after maternal treatment with buprenorphine-naloxone vs other forms of MAT. Of the buprenorphinenaloxoneeexposed neonates, the need for NAS treatment ranged from 25% to 64%, whereas neonates exposed to other forms of MAT ranged from 51% to 80%.…”

“…Of the buprenorphinenaloxoneeexposed neonates, the need for NAS treatment ranged from 25% to 64%, whereas neonates exposed to other forms of MAT ranged from 51% to 80%. 20,21,23, 24 Gawronski et al 21 and Wiegand et al 20 reported a significantly decreased need for NAS treatment when buprenorphine-naloxoneeexposed neonates were compared with those exposed to methadone. Mullins et al 23 reported that significantly fewer buprenorphine-naloxoneeexposed neonates required treatment for NAS than those exposed to buprenorphine alone; however, this finding did not persist after adjustment for confounders.…”

“…Length of hospital stay was evaluated in 3 studies and ranged from 5.6 to 9 days for buprenorphine-naloxoneeexposed neonates, compared with 6 to 10 days for neonates exposed to other forms of MAT. 20,21,23 Wiegand et al 20 reported a significant decrease in length of hospitalization, as well as peak NAS scores, among buprenorphine-naloxonee exposed neonates when compared with methadone-exposed neonates. Gawronski and colleagues 21 reported a trend toward a decreased treatment duration for NAS and lower cumulative treatment medication dose required among buprenorphine-naloxoneeexposed neonates as compared with methadoneexposed neonates.…”

Naloxone and Metabolites Quantification in Cord Blood of Prenatally Exposed Newborns and Correlations with Maternal Concentrations

“…Several observational cohort studies reviewing neonatal outcomes when their mothers were treated with buprenorphine/naloxone demonstrated outcomes similar to those whose mothers were treated with methadone or buprenorphine monotherapy. [6][7][8][9] Citing lack of safety data, most authorities recommend that pregnant women who are treated with buprenorphine/ naloxone at conception switch to either buprenorphine monotherapy or methadone. 3,19,20 Safety concerns may include fetal or neonatal withdrawal from the presence of naloxone in combination with opioids; adult studies show that if naloxone is given sublingually it does not affect the efficacy or pharmacological properties of buprenorphine.…”

“…5 Advantages for utilizing buprenorphine compared with methadone include its office-based prescribing ability (vs. daily distribution of methadone), lower drug interaction profile, lower overdose potential, and less severe NAS. 5 There is emerging information on the treatment of pregnant women utilizing the MAT combination medication buprenorphine/naloxone, [6][7][8][9] which is widely used in the addiction medicine treatment community for nonpregnant individuals.…”