Oxcarbazepine (Trileptal®, Oxtellar XR®)

Selected References:

  • Artama M, et al. 2006. Antiepileptic drug use and birth rate in patients with epilepsy-a population-based cohort study in Finland. Hum Reprod 21:2290-5.
  • Bech LF, et al. 2018. In utero exposure to antiepileptic drugs is associated with learning disabilities among offspring. J Neurol Neurosurg Psychiatry 89:1324–1331.
  • Birnbaum AK, et al. 2020. Antiepileptic drug exposure in infants of breastfeeding mothers with epilepsy. JAMA Neurol 77(4):441-450.
  • Bjork M-H, et al. 2022. Association of prenatal exposure to antiseizure medication with risk of autism and intellectual disability. JAMA Neurology 79(7):672-81.
  • Blotière PO, et al. 2019. Risks of 23 specific malformations associated with prenatal exposure to 10 antiepileptic drugs. Neurology 93(2):e167-e80.
  • Blotière PO, et al. 2020. Risk of early neurodevelopmental outcomes associated with prenatal exposure to the antiepileptic drugs most commonly used during pregnancy: a French nationwide population-based cohort study. BMJ Open 10(6):e034829.
  • Bruno MK, Harden CL. 2002. Epilepsy in pregnant women. Curr Treat Options Neurol 4(1):31-40.
  • Bülau P, et al. 1988. Pharmacokinetics of oxcarbazepine and 10-hydroxy-carbazepine in the newborn child of an oxcarbazepine-treated mother. Eur J Clin Pharmacol 34:311–3.
  • Chen CY, et al. 2017. In utero oxcarbazepine exposure and neonatal abstinence syndrome: Case report and brief review of the literature. Pharmacotherapy 37:e71–e5.
  • Christensen J, et al. 2015. Apgar-score in children prenatally exposed to antiepileptic drugs: a population-based cohort study. BMJ Open 5(9):e007425.
  • Cohen JM, et al. 2019. Anticonvulsant mood stabilizer and lithium use and risk of adverse pregnancy outcomes. J Clin Psychiatry 2019;80(4).
  • Cohen JM, et al. 2023. Comparative safety of antiseizure medication monotherapy for major malformations. Ann Neurol. 93(3):551-562.
  • Daugaard CA, et al. 2020. Association of prenatal exposure to valproate and other antiepileptic drugs with intellectual disability and delayed childhood milestones. JAMA Netw Open 3(11):e2025570.
  • Dreier JW et al. 2023. Prenatal exposure to antiseizure medication and incidence of childhood- and adolescence-onset psychiatric disorders. JAMA Neurology 80(6):568-577.
  • Eisenschenk S. 2006. Treatment with oxcarbazepine during pregnancy. Neurologist 12(5):249-254.
  • Friis ML, et al. 1993. Therapeutic experiences with 947 epileptic out-patients in oxcarbazepine treatment. Acta Neurol Scand 87(3):224-227.
  • Gentile S. 2003. Oxcarbazepine in pregnancy and lactation. Clin Drug Investig 23:687.
  • Guo Y, et al. 2021. A comparative study of the effects of valproate and oxcarbazepine on sexual function, sperm quality, and sex hormones in males with epilepsy. Biomed Res Int 2021:6624101.
  • Hvas CL, et al. 2000. Epilepsy and pregnancy: effect of antiepileptic drugs and lifestyle on birthweight. Br J Obstet Gynaecol 107:896-902.
  • Isojarvi JI, et al. 2004. Effect of epilepsy and antiepileptic drugs on male reproductive health. Neurology 62:247-53.
  • Jacobsen PE, et al. 2014. Prenatal exposure to antiepileptic drugs and dental agenesis. PLoS One 9(1):e84420.
  • Johnson K, et al. 2021. Retrospective Analysis of Oxcarbazepine in Pregnant Women With Substance Use Disorders: Focus on Safety. Journal of Pharmacy Practice 34(1):28-34.
  • Kaaja E, et al. 2003. Major malformations in offspring of women with epilepsy. Neurology 60:575-9.
  • Lloyd P, et al. 1994. Clinical Pharmacology and Pharmacokinetics of Oxcarbazepine. Epilepsia 35(s3).
  • Luef G, et al. 2009. Oxcarbazepine treatment in male epilepsy patients improves pre-existing sexual dysfunction. Neurologica 119(2):94-99.
  • Lutz UC, et al. 2007. Oxcarbazepine treatment during breast-feeding: a case report. J Clin Psychopharmacol 27:730–2.
  • Meischenguiser R, et al. 2003. Major malformations in offspring of women with epilepsy. [Letter] Neurology 61:1631.
  • Meischenguiser R, et. al. 2004. Oxcarbazepine in pregnancy: clinical experience in Argentina. Epilepsy Behav 5:163-167.
  • Miller M, et al. 2003. Major malformations in offspring of women with epilepsy. [Letter] Neurology 61:1631.
  • Mølgaard-Nielsen D, Hviid A. 2011. Newer-generation antiepileptic drugs and the risk of major birth defects. JAMA 305(19):1996-2002.
  • Montouris G. 2005. Safety of the newer antiepileptic drug oxcarbazepine during pregnancy. Curr Med Res Opin 21:693-701.
  • 2020. Trileptal® Prescribing Information. Available at URL: https://www.novartis.us/sites/www.novartis.us/files/trileptal.pdf.
  • Ohman I, et al. 2009. Pharmacokinetics of oxcarbazine in neonatal period and during lactation. Epilepsia 50(Suppl. 4):238. Abstract.
  • Rolnitsky A, et al. 2013. In utero oxcarbazepine and a withdrawal syndrome, anomalies, and hyponatremia. Pediatr Neurol 2013;48(6):466-8.
  • Supernus Pharmaceuticals. 2018. Otexllar XR® Prescribing Information. Available at URL: https://www.oxtellarxrhcp.com/assets/OxtellarXRPrescribingInformation.pdf.
  • Tomson T, et al. 2015. Antiepileptic drugs and intrauterine death: A prospective observational study from EURAP. Neurology 85: 580-588.
  • Tomson T, et al. 2018. Comparative risk of major congenital malformations with eight different antiepileptic drugs: a prospective cohort study of the EURAP registry. Lancet Neurol 17(6):530-538.
  • Trivedi M, et al. 2018. Spontaneous fetal loss in women with epilepsy: prospective data from pregnancy registry in India. Epilepsy Research 146:50-53.
  • Vajda F, et al. 2018. Anti-epieptic drug exposure and risk of foetal death in utero. Acta Neurol Scand 137(1):20-23.
  • Veiby G, et al. 2014. Fetal growth restriction and birth defects with newer and older antiepileptic drugs during pregnancy. J Neurol 261:579-588.
  • Videman M, et al. 2016. Evidence for spared attention to faces in 7-month-old infants after prenatal exposure to antiepileptic drugs. Epilepsy Behav 64(Pt A):62-68.
  • Weston J, et al. 2016. Monotherapy treatment of epilepsy in pregnancy: congenital malformation outcomes in the child. Cochrane Database Syst Rev 11(11):CD010224.
  • Wu D, et al. 2018. The effects of oxcarbazepine, levetiracetam, and lamotrigine on semen quality, sexual function, and sex hormones in male adults with epilepsy. Epilepsia 59(7):1344-1350.
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Oxcarbazepine (Trileptal®, Oxtellar XR®)

Selected References

  • Blandthorn J, et al. 2018. Managing opioid overdose in pregnancy with take-home naloxone. Aust N Z J Obstet Gyneacol 58(4):460-62.
  • Debelak K, et al. 2013. Buprenorphine + Naloxone in the treatment of opioid dependence during pregnancy-initial patient care and outcome data. Am J Addict; 22(3):252-54.
  • Flannagan KS, et al. 2020. Prescription opioid use among populations of reproductive age: effects on fertility, pregnancy loss, and pregnancy complications. Epidemiologic reviews. 42(1): 117-33.
  • Gawronski KM, et al. 2014. Neonatal outcomes following in utero exposure to buprenorphine/naloxone or methadone. 2:2050312114530282.
  • Goshgarian G, et al. Prenatal Buprenorphine/Naloxone or Methadone Use on Neonatal Outcomes in Michigan. Cureus.14(8).
  • Griffiths S, et al. 2021. Use of injectable opioid agonist therapy in a in-patient setting for a pregnant patient with opioid use disorder: A case report. Journal of Addiction Medicine. 15(5): 435-38.
  • Jones HE & Kraft WK. 2019. Analgesia, Opioids, and Other Drug Use During Pregnancy and Neonatal Abstinence Syndrome. Clin Perinatol; 46(2):349-366.
  • Jansson LM, et al. 2024. Buprenorphine-Naloxone Maintenance and Lactation. Journal of Human Lactation 40(1): 113-19.
  • Jumah NA, et al. 2016. Observational study of the safety of buprenorphine+naloxone in pregnancy in a rural and remote population. BMJ Open; 6(10):e011774.
  • Kanervo M, et al. 2023. Buprenorphine‐naloxone, buprenorphine, and methadone throughout pregnancy in maternal opioid use disorder. Acta Obstetricia et Gynecologica Scandinavica. 102(3): 313-22.
  • Kanervo M, et al. 2024. Intrauterine exposure to maternal opioid maintenance treatment and associated risk factors may impair child growth. Acta Paediatrica.


Oxcarbazepine (Trileptal®, Oxtellar XR®)

Selected References:

  • Aarskog D. 1975. Association between maternal intake of diazepam and oral clefts. Lancet 2:921.
  • Borgatta L, et al. 1997. Clinical significance of methohexital, meperidine, and diazepam in breast milk. J Clin Pharmacol 37:186-92.
  • Brandlistuen R, et al. 2017. Association of prenatal exposure to benzodiazepines and child internalizing problems: A sibling-controlled cohort study. PLoS ONE 12(7):e0181042.
  • Calderon-Margalit R, et al. 2009. Risk of preterm delivery and other adverse perinatal outcomes in relation to maternal use of psychotropic medications during pregnancy. Am J Obstet Gynecol 201(6):579.e1-579.e8.
  • Chen VC, et al. 2022. Association of prenatal exposure to benzodiazepines with development of autism spectrum and attention-deficit/hyperactivity disorders. JAMA Netw Open. 5(11): e2243282.
  • Czeizel, A. 1988. Lack of evidence of teratogenicity of benzodiazepine drugs in Hungary. Reproductive Toxicology 1(3):183-188.
  • Czeizel A, et al. 1999. The effect of diazepam and promethazine treatment during pregnancy on the somatic development of human offspring. Neurotoxicol Teratol 21(2):157-167.
  • Engeland A, et al. 2013. Effects of preconceptional paternal drug exposure on birth outcomes: cohort study of 340 000 pregnancies using Norwegian population-based databases. Br J Clin Pharmacol 75(4): 1134-41.
  • Freeman M, et al. 2018. Obstetrical and neonatal outcomes after benzodiazepine exposure during pregnancy: Results from a prospective registry of women with psychiatric disorders. General Hospital Psychiatry 53: 73-79.
  • Grigoriadis S, et al. 2020. Resultados del embarazo y el parto después de la exposición a benzodiazepinas: una revisión sistemática y metanálisis. Revista Canadiense de Psiquiatría. 65(12): 821-34.
  • Jensen AG, et ak, 2022. Prenatal exposure to benzodiazepines and the development of the offspring: a systematic review. Neurotoxicol Teratol. 91:107078.
  • Kjaer D, et al. 2007. Use of phenytoin, phenobarbital, or diazepam during pregnancy and risk of congenital abnormalities: a case-time-control study. Pharmacoepidemiol Drug Saf 16(2):181-188.
  • Laegreid L, et al. 1990. Congenital malformations and maternal consumption of benzodiazepines: a case-control study. Dev Med Child Neurol 32(5):432-441.
  • Laegreid L, et al. 1992. Neurodevelopment in late infancy after prenatal exposure to benzodiazepines–a prospective study. Neuropediatrics 23(2):60-67.
  • Laegreid L, et al. 1992. The effect of benzodiazepines on the fetus and the newborn. Neuropediatrics 23(1):18-23.
  • Noh Y, et al. 2022. First-trimester exposure to benzodiazepines and risk of congenital malformations in offspring: A population-based cohort study in South Korea. PLoS medicine. 19(3): e1003945.
  • Ornoy A, et al. 1998. Is benzodiazepine use during pregnancy really teratogenic? Reproductive Toxicology 12(5):511-515.
  • Rementeria J, Bhatt K. 1977. Withdrawal symptoms in neonates from intrauterine exposure to diazepam. J Pediatr 90(1):123-126.


Oxcarbazepine (Trileptal®, Oxtellar XR®)

Selected References:

  • Berle JO, et al. 2004. Breastfeeding during maternal antidepressant treatment with serotonin reuptake inhibitors: infant exposure, clinical symptoms, and cytochrome P450 genotypes. J Clin Psychiatry 65:1228-34. PMID: 15367050
  • Briggs G, et al. 2022. Drugs in Pregnancy and Lactation: Wolters Kluwer; 12th edition: 950-951
  • Brunel P, et al. 1994. [Follow-up of 151 pregnant women exposed to antidepressant treatment (MAOI excluded) during organogenesis.] Therapie 49:117-122.
  • Eggermont E. 1973. Withdrawal symptoms in neonate associated with maternal imipramine therapy. Lancet 2:680.
  • Misri S & Sivertz K. 1991. Tricyclic drugs in pregnancy and lactation: a preliminary report. Int J Psychiatry Med 21(2):157-71.
  • Grzeskowiak, LE, et al. 2022. Perinatal antidepressant use and breastfeeding outcomes: Findings from the Norwegian Mother, Father and Child Cohort Study. Acta Obstetricia et Gynecologica Scandinavica. 101(30): 344-54.
  • Mitchell JE and Popkin MK: Antidepressant drug therapy and sexual dysfunction in men: a review. J Clin Psychopharm 3:76-79, 1983.
  • Nulman I, et al. 1997. Neurodevelopment of children exposed in utero to antidepressant drugs. N Engl J Med 336:258-62.
  • Overo KF, et al. 1997. Interaction of perphenazine with the kinetics of nortriptyline. Acta Pharmacol Toxicol; 40:97-105.
  • Schoretsanitis S, et al. 2020. The impact of pregnancy on the pharmacokinetics of antidepressants: a systematic critical review and meta-analysis. Expert Opin Drug Metab Toxicol; 16(5):431-440.
  • Semet, M., et al. 2017. The impact of drugs on male fertility: a review. Andrology 5(4): 640-663.
  • Shearer WT, et al. 1972. Urinary retention in a neonate secondary to maternal ingestion of nortriptyline. J Pediatr 81:570-2.
  • US Preventive Services Task Force, Curry SJ, et al. 2019. Interventions to Prevent Perinatal Depression: US Preventive Services Task Force Recommendation Statement. JAMA 321(6):580-587.
  • Wall-Wieler, E, et al. 2020. Antidepressant use around conception, prepregnancy depression, and risk of ectopic pregnancy. The Canadian Journal of Psychiatry,65(12):845-53.
  • Webster PA. 1973. Withdrawal symptoms in neonates associated with maternal antidepressant therapy. Lancet 2(7824):318-9.
  • Weissman AM, et al. 2004. Pooled analysis of antidepressant levels in lactating mothers, breast milk, and nursing infants. Am J Psychiatry 161:1066-78.
  • Wisner KL, et al. 2002. Postpartum depression. N Engl J Med. 347:194-9.
  • Xing, D, et al. 2020. Maternal use of antidepressants during pregnancy and risks for adverse perinatal outcomes: a meta-analysis. Journal of Psychosomatic Research, 137:110231.


Oxcarbazepine (Trileptal®, Oxtellar XR®)

Selected References

  • American College of Obstetricians and Gynecologists (ACOG). 2017. Committee Opinion No. 723. Guidelines for diagnostic imaging during pregnancy and lactation. Obstet Gynecol, 130(4):933-934.
  • American College of Radiology. 2020.ACR Manual on MR Safety. [PDF file]. Retrieved from https://www.acr.org/-/media/ACR/Files/Radiology-Safety/MR-Safety/Manual-on-MR-Safety.pdf.
  • Chartier AL, et al. 2019. The safety of maternal and fetal MRI at 3 T. American Journal of Roentgenology, 213(5): 1170–1173.
  • Lum M, Tsiouris AJ. 2020. MRI safety considerations during pregnancy. Clin Imaging; 62:69-75.
  • Maralani PJ, et al.2023. Safety of Magnetic Resonance Imaging in Pregnancy. Radiologie (Heidelb). 63(Suppl 2):34-40
  • Mervak BM, et al. 2019. MRI in pregnancy: Indications and practical considerations. Journal of Magnetic Resonance Imaging, JMRI, 49(3):621–631.
  • Ray JG, et al. 2016. Association between MRI exposure during pregnancy and fetal and childhood outcomes. JAMA, 316(9):952-961.