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Buprenorphine (Buprenex®)

February 1, 2025

Selected References:

  • American College of Obstetricians and Gynecologists (ACOG). 2017. Reaffirmed October 2021. Committee Opinion No. 711: Opioid use and opioid use disorder in pregnancy. Obstet Gynecol, 130:e81-e94. 
  • American Society of Addiction Medicine. 2017. Clinical Recommendations: Opioid Use and Opioid Use Disorder in Pregnancy. A Joint Opinion of the ACOG’s Committee on Obstetric Practice and ASAM. Available at https://www.asam.org/quality-care/clinical-recommendations/OUD-in-Pregnancy [retrieved February 2025]. 
  • Anderson JM, et al. 2020. Prenatal exposure to methadone or buprenorphine and long-term outcomes: a meta-analysis. Early Human Development, 143:104997. 
  • Asad M, et al. 2024. Reviewing the impact of maternal opioid use disorder on fetal development and long-term pediatric health outcomes. Cureus, 16(10):e72192. 
  • Aslaksen AK, et al. 2024. Children had increased risks of impaired motor and visual-motor skills after prenatal exposure to opioid maintenance therapy. Acta Paediatr, 113(6):1331-1339. 
  • Aslaksen AK, et al. 2024. Visual function in Norwegian children aged 5-13 years with prenatal exposure to opioid maintenance therapy: a case-control study. Acta Ophthalmol, 102(4):409-420. 
  • Austin A, et al. 2021. Prenatal use of medication for opioid use disorder and other prescription opioids in cases of neonatal opioid withdrawal syndrome: North Carolina Medicaid, 2016-2018. Am J Public Health, 111(9):1682-1685. 
  • Bello JK, et al. 2024. Pregnancy rates among women treated with medication for opioid use disorder. J Gen Intern Med, 39(8):1342-1348. 
  • Caritis SN, Venkataramanan R. A pharmacologic evaluation of buprenorphine in pregnancy and the postpartum period. J Addict Med, 19(2):129-134.  
  • Chao CR, et al. 2023. Effects of medications for opioid use disorder (MOUD) on fetal brain and cranial measurements. Neurotoxicol Teratol, 97:107177.  
  • Conradt E, et al. 2019. Prenatal opioid exposure: Neurodevelopmental consequences and future research priorities. Pediatrics, 144(3):e20190128. 
  • Coulson C, et al. 2021. Association of maternal buprenorphine or methadone dose with fetal growth indices and neonatal abstinence syndrome. Am J Perinatol, 38(01):028-036. 
  • Dean MP, et al. 2025. Increased prevalence of skeletal anomalies on ultrasound evaluation of buprenorphine-exposed human fetuses. South Med J, 118(1):39-44. 
  • Dorey A, et al. 2019. Possible buprenorphine toxicity in a breastfeeding neonate. Clin Toxicol, 57:889-890. 
  • Gawronski KM, et al. 2014. Neonatal outcomes following in utero exposure to buprenorphine/naloxone or methadone. SAGE Open Medicine, 2:2050312114530282.  
  • Giovannini E, et al. 2024. Fetal and infant effects of maternal opioid use during pregnancy: a literature review including clinical, toxicological, pharmacogenomic, and epigenetic aspects for forensic evaluation. Children (Basel), 11(3):278. 
  • Handal M, et al. 2019. Prenatal exposure to opioid maintenance treatment and neonatal outcomes: nationwide registry studies from the Czech Republic and Norway. Pharmacol Res Perspect, 7(5):e00501. 
  • Harris E. 2023. Buprenorphine treatment may be safer than methadone during pregnancy. JAMA, 331(7):555. 
  • Hasan M, et al. 2024. Neurodevelopmental outcomes in children prenatally exposed to opioid maintenance treatment: a population-based study. Pharmacotherapy, 44(10):770-781. 
  • Hubbell A, et al. 2024. Extended-release buprenorphine in pregnancy. Am J Addict, 33(3):354-356. 
  • Ito, S. 2018. Opioids in breast milk: Pharmacokinetic principles and clinical implications. J Clin Pharmacol, 58 Suppl 10:S151-S163. 
  • Jansson LM, et al. 2017. Maternal buprenorphine treatment and infant outcome. Drug Alcohol Depen, 180:56-61. 
  • Jansson LM, et al. 2016. Maternal buprenorphine maintenance and lactation. J Hum Lact, 32:675-81. 
  • Jones HE, et al. 2012. Buprenorphine treatment of opioid-dependent pregnant women: a comprehensive review. Addiction 107, (Suppl. 1):5–27. 
  • Jones JD, et al. 2012. Polydrug abuse: a review of opioid and benzodiazepine combination use. Drug Alcohol Depend, 125(1-2):8–18. 
  • Hemmati Z, et al. 2022. Ophthalmic outcomes in children exposed to opioid maintenance treatment in utero: a systematic review and meta-analysis. Neurosci Biobehav Rev, 136:104601. 
  • Jansson LM, et al. 2024. Buprenorphine-naloxone maintenance and lactation. J Hum Lact, 40(1):113-119. 
  • Jarlenski M, et al. 2024. Association between buprenorphine dose and outcomes among pregnant persons with opioid use disorder. Am J Obstet Gynecol, S0002-9378(24)01178-5. 
  • Kacinko S, et al. 2008. Correlations of maternal buprenorphine dose, buprenorphine, and metabolite concentrations in meconium with neonatal outcomes. Clin Pharmacol Ther, 84(5):604-612. 
  • Kallenbach K, et al. 2012. Predicting treatment for neonatal abstinence syndrome in infants born to women maintained on opioid agonist medication. Addiction 107, (Suppl. 1):45-52. 
  • Kanervo, MM, et al. 2023. Buprenorphine-naloxone, buprenorphine, and methadone throughout pregnancy in maternal opioid use disorder. Acta Obstet Gynecol Scand, 102:313-322. 
  • Kanervo M, et al. 2024. Intrauterine exposure to maternal opioid maintenance treatment and associated risk factors may impair child growth. Acta Paediatr, 113(7):1579-1591. 
  • Kanervo M, et al. 2024. Extended-release versus oral buprenorphine as opioid maintenance treatment during pregnancy-maternal and neonatal outcomes. Eur J Obstet Gynecol Reprod Biol, 297:106-110. 
  • Kinsella M, et al. 2022. Buprenorphine compared with methadone in pregnancy: a systematic review and meta-analysis. Subst Use Misuse, 57(9):1400-1416.  
  • Knittel AK, et al. 2023. Neonatal outcomes after medications for opioid use disorder during pregnancy in a state women’s prison facility, 2016-2019. J Addict Med, 17(5):587-591. 
  • Kocherlakota P. 2014. Neonatal bstinence syndrome. Pediatrics, 134(2):e547-e561. 
  • Krans EE, et al. 2021. Outcomes associated with the use of medications for opioid use disorder during pregnancy. Addiction, 116(12):3504-3514. 
  • Kumar N, et al. 2021. Impact of opioid maintenance treatment during pregnancy on neonatal birth weight and head circumference. J Neonatal Perinatal Med, 14(4):475-484.  
  • Kushnir A, et al. 2023. Neonatal abstinence syndrome in infants with prenatal exposure to methadone versus buprenorphine. Children (Basel), 10(6):1030. 
  • Mallinson DC, et al. 2024. Maternal opioid use disorder and infant mortality in Wisconsin, United States, 2010-2018. Prev Med, 181:107914. 
  • Marc B, et al. 2025. Is buprenorphine maternal dose associated with neonatal opioid withdrawal syndrome severity? Am J Addict, 34(1):15-20. 
  • Nelson LF, et al. 2020. Cognitive outcomes of young children after prenatal exposure to medications for opioid use disorder: a systematic review and meta-analysis. JAMA Netw Open,3(3):e201195. 
  • Reece-Stremtan S, Marinelli KA. 2015. ABM Clinical Protocol #21: Guidelines for breastfeeding and substance use or substance use disorder, Revised 2015. Breastfeed Med, 10(3):135-141. 
  • Ordean A, Tubman-Broeren M. 2023. Safety and efficacy of buprenorphine-naloxone in pregnancy: a systematic review of the literature. Pathophysiology, 30(1):27-36. 
  • Patel N, et al. 2024. Weaning buprenorphine in pregnant patients. J Matern Fetal Neonatal Med, 37(1):2337711. 
  • Patel NB, Parilla BV. 2024. Buprenorphine induction using microdosing for the management of opioid use disorder in pregnancy. AJP Rep, 14(1):e88-e90.  
  • Schuckit MA. 2016. Treatment of opioid-use disorders.  N Engl J.Med, 375:357–68. 
  • Shah D, et al. 2025. Outpatient tapering of buprenorphine in opioid use disorder pregnancies may improve neonatal outcomes. J Perinatol, doi: 10.1038/s41372-025-02211-6. 
  • Smith D, et al. 2024. Evaluating the effect of maternal opioid maintenance dose on the NOWS-COS outcome criteria: a pilot study. Clin Pediatr (Phila), 63(12):1670-1677. 
  • Soyka M, 2013. Buprenorphine use in pregnant opioid users: a critical review. CNS Drugs, 27(8):653-662. 
  • Staszewski CL, et al. 2020. Comparison of buprenorphine and methadone in the management of maternal opioid use disorder in full term pregnancies. J Perinat Med Sep, 25;48(7):677-680. 
  • Straub L, et al. 2024. Comparative safety of in utero exposure to buprenorphine combined with naloxone vs buprenorphine alone. JAMA, 332(10):805-816. 
  • Suarez EA, et al. 2022. Buprenorphine versus methadone for opioid use disorder in pregnancy. N Engl J Med, 387(22):2033-2044. 
  • Suarez EA, et al. 2024. First trimester use of buprenorphine or methadone and the risk of congenital malformations. JAMA Intern Med, 184(3):242-251. 
  • Sundelin-Wahlsten V, Sarman I. 2013. Neurobehavioural development of preschool-age children born to addicted mothers given opiate maintenance treatment with buprenorphine during pregnancy. Acta Paediat, 102(5): 544-549. 
  • Wiegand SL, et al. 2015. Buprenorphine and naloxone compared with methadone treatment in pregnancy. Obstet Gynecol, 125(2):363-368. 
  • Wouldes TA, Lester BM. 2023. Opioid, methamphetamine, and polysubstance use: perinatal outcomes for the mother and infant. Front Pediatr, 11:1305508. 

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