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Medications and More during pregnancy and breastfeeding

Carbamazepine

Selected References:

  • Adams J, et al. 2022. Neuropsychological effects in children exposed to anticonvulsant monotherapy during gestation: Phenobarbital, carbamazepine, and phenytoin. Epilepsy Behav; 127:108533. 
  • Antonucci R, et al. 2018. Maternal carbamazepine therapy and unusual adverse effects in a breastfed infant. Breastfeed Med; 13(2):155-157. 
  • Baker GA, et al. 2015. IQ at 6 years after in utero exposure to antiepileptic drugs: a controlled cohort study. Neurology; 84(4):382-390. 
  • Battino D, et al. 2024. Risk of major congenital malformations and exposure to antiseizure medication monotherapy. JAMA Neurol; 81(5):481-489. 
  • Bech BH, et al. 2014. Use of antiepileptic drugs during pregnancy and risk of spontaneous abortion and stillbirth: population based cohort study. BMJ; 349:g5159. 
  • 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 Neurol. 79(7):672-681.  
  • Blotiere 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. 7;10(6):e034829. 
  • Bromley RL, et al. 2013. The prevalence of neurodevelopmental disorders in children prenatally exposed to antiepileptic drugs. J Neurol Neurosurg Psychiatry. 84(6):637-643. 
  • Bromley R, et al. 2023. Monotherapy treatment of epilepsy in pregnancy: congenital malformation outcomes in the child. Cochrane Database Syst Rev; 29;8(8):CD010224.  
  • Campbell E, et al. 2014. Malformation risks of antiepileptic drug monotherapies in pregnancy: updated results from the UK and Ireland Epilepsy and Pregnancy Registers. J Neurol Neurosurg Psychiatry; 85(9):1029-1034. 
  • Canger R, et al. 1999. Malformations in offspring of women with epilepsy: a prospective study.  Epilepsia; 40(9):1231-1236. 
  • Craig JJ, et al. 2022. Epilepsy and pregnancy: identifying risks. Pract Neurol; 22(2):98-106. 
  • 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. 
  • Cohen JM, et al. 2023. Comparative safety of antiseizure medication monotherapy for major malformations. Ann Neurol; 93(3):551-562. 
  • Cummings C, et al. 2011. Neurodevelopment of children exposed in utero to lamotrigine, sodium valproate and carbamazepine. Arch Dis Child; 96(7):643-647. 
  • Davanzo R, et al. 2013.  Italian Journal of Pediatrics; 39:50-61. 
  • Deshmukh U, et al. 2016. Behavioral outcomes in children exposed prenatally to lamotrigine, valproate, or carbamazepine. Neurotoxicol Teratol; 54:5-14. 
  • Fried S, et al. 2004.  Malformation rates in children of women with untreated epilepsy: a meta-analysis. Drug Saf; 27(3):197-202. 
  • Gaily E, et al. 2004. Normal intelligence in children with prenatal exposure to carbamazepine. Neurology 62:28-32. 
  • Gladstone DJ, et al. 1992. Course of pregnancy and fetal outcome following maternal exposure to carbamazepine and phenytoin: a prospective study. Reprod Toxicol; 6:257-261. 
  • Harden CL. 2008. Antiepileptic drug teratogenesis:  what are the risks for congenital malformations and adverse cognitive outcomes? Int Rev Neurobiol; 83:205-213. 
  • Hernandez-Diaz S, et al. 2000. Folic acid antagonists during pregnancy and the risk of birth defects. N Engl J Med; 343(22):1608-1614. 
  • Hernandez-Diaz S, et al. 2025. Use of Antiseizure Medications Early in Pregnancy and the Risk of Major Malformations in the Newborn. Neurology; 105(3):e213786.  
  • Holmes LB, et al. 2024. Facial dysmorphology in children exposed in pregnancy to anticonvulsant medications correlates with deficits in IQ. Am J Med Genet; 2024;194A:e63511. 
  • Honybun E, et al. 2026. Neurocognitive Outcomes of In Utero Exposure to Antiseizure Medication: An Australian Cohort Study. Neurology; 107(1):e218122 
  • Huber-Mollema Y, et al. 2020. Neurocognition after prenatal levetiracetam, lamotrigine, carbamazepine, or valproate exposure. J Neurol; 267(6):1724-1736. 
  • Husebye E, et al. 2020. Language impairment in children aged 5 and 8 years after antiepileptic drug exposure in utero – the Norwegian Mother and Child Cohort Study. European Journal of Neurology; 27.3:667-675. 
  • Li Y, Meador KJ. 2022. Epilepsy and Pregnancy. Continuum (Minneap Minn); 28(1):34-54. 
  • Jones KL, et al. 1989.  Patterns of malformations in the children treated with carbamazepine during pregnancy. N Engl J Med; 320(25):1661-1666. 
  • Kacirova I, et al. 2021. Therapeutic monitoring of carbamazepine and its active metabolite during the 1st postnatal month: Influence of drug interactions. Biomed Pharmacother; 137:111412. 
  • Kacirova I, et al. 2022. Carbamazepine and carbamazepine-epoxide concentrations in mothers, colostrum, and breastfed newborns: Comparison with concentrations determined during delivery and in the mature milk period. Biomedicine & Pharmacotherapy; 151:113176. 
  • Kallen AJB. 1994. Maternal carbamazepine and infant spina bifida. Reprod Toxicol 8(3):203-205. 
  • Kaplan YC, et al. 2021. Use of phenytoin, phenobarbital carbamazepine, levetiracetam lamotrigine and valproate in pregnancy and breastfeeding: risk of major malformations, dose-dependency, monotherapy vs polytherapy, pharmacokinetics and clinical implications. Curr Neuropharmacol; 19(11):1805-1824. 
  • Karain A, et al. 2025. Educational outcomes associated with prenatal exposure to antiseizure medications: A systematic literature review and meta-Analysis. Seizure; 32:37-45.  
  • Leite ML, et al. 2024. Obstetric and neonatal outcomes, antiseizure medication profile, and seizure types in pregnant women in a vulnerability state from Brazil. PLoS One; 1;19(4):e0291190. 
  • Meador KJ, et al. 2009. Cognitive function at 3 years of age after fetal exposure to antiepileptic drugs.  N Engl J Med; 360(16):1597-1605. 
  • Margulis A, et al. 2019. Relation of in-utero exposure to antiepileptic drugs to pregnancy during and size at birth. PLoS One; 14(8):e0214180. 
  • Mazzone PP, et al. 2023. Comparison of perinatal outcomes for women with and without epilepsy: a systematic review and meta-analysis. JAMA Neurol; 80(5):484-494. 
  • Meador KJ, et al. 2014. Breastfeeding in children of women taking antiepileptic drugs cognitive outcomes at age 6 years. JAMA Pediatr; 168(8):729-736. 
  • Morrell M. 1996. The new antiepileptic drugs and women:  efficacy, reproductive health, pregnancy and fetal outcome. Epilepsia 37(Suppl. 6):S34-S44. 
  • Novartis. (n.d.). Tegretol – Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/018927Orig1s061;016608Orig1s122;020234Orig1s055lbl.pdf. Accessed July 2026. 
  • Nulman I, et al. 1997. Findings in children exposed in utero to phenytoin and carbamazepine monotherapy: independent effects of epilepsy and medications. Am J Med Genet; 68:18-24. 
  • O’Brien MD and Gilmour-White SK. 2005. Management of epilepsy in women treated with carbamazepine during pregnancy. Postgrad Med J; 81(955):278-285. 
  • Ornoy A and Cohen E.  1996.  Outcome of children born to epileptic mothers treated with carbamazepine during pregnancy. Arc Dis Child; 75:517-520 
  • Patel N, et al. 2018. Mood-stabilizing anticonvulsants, spina bifida, and folate supplementation: commentary. J Clin Psychopharmacol; 38(1):7-10. 
  • Rosa FW. 1991. Spina bifida in infants of women treated with carbamazepine during pregnancy. N Engl J Med; 324(10)674-677. 
  • Samren EB, et al. 1999. Antiepileptic drug regimens and major congenital abnormalities in the offspring. Ann Neurol; 46(5):739-746. 
  • Scolnik D, et al. 1994. Neurodevelopment if children exposed in utero to phenytoin and carbamazepine monotherapy. JAMA; 271(10):767-770. 
  • Shawahna R, Zaid L. 2022. Concentrations of antiseizure medications in breast milk of lactating women with epilepsy: A systematic review with qualitative synthesis. Seizure; 98:57-70.  
  • Straub L, et al. 2026. Prenatal antiseizure drug exposure and risk of neurodevelopmental disorders in children: population based cohort study. BMJ; 392:e085725.  
  • Tang W, et al. 2023. Adverse perinatal pregnancy outcomes in women with schizophrenia: A systematic review and meta-analysis. Schizophr Res; 262:156-167.  
  • Tomson T and Barrino D.  2008. Teratogenic effects of antiepileptic drugs. Seizure; 17(2):166-171. 
  • Tomson T and Klein P. 2015. Fine-tuning risk assessment with antiepileptic drug use in pregnancy. Neurology; 84(4):339-340. 
  • Tomson T, et al. 2015. Antiepileptic drugs and intrauterine death: A prospective observational study from EURAP. Neurology; 85(7):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. 
  • U.S. Centers for Disease Control and Prevention. 2026. Data and statistics on Spina Bifida. https://www.cdc.gov/spina-bifida/data/.  
  • Vajda F. 2014. Epilepsy: Effects of exposure to antiepileptic drugs during development. Nat Rev Neurol; 10:11-12. 
  • Vajda F, et al. 2018. Anti-epileptic drug exposure and risk of foetal death in utero. Acta Neurol Scand; 137(1):20-23. 
  • Wallace H, et al. 1998. Age-specific incidence and prevalence rates of treated epilepsy in an unselected population of 2,052,922 and age-specific fertility rates of women with epilepsy. Lancet; 352:1970-1973. 
  • Weston J, et al. 2016. Monotherapy treatment of epilepsy in pregnancy: congenital malformation outcomes in the child. Cochrane Database Syst Rev; 11:Cd010224. 
  • Wide K, et al. 2000. Psychomotor development and minor anomalies in children exposed to antiepileptic drugs in utero: A prospective population-based study. Dev Med Child Neurol; 42:87-92. 
  • Wiggs K, et al. 2020. Anti-seizure medication use during pregnancy and risk of ASD and ADHD in children. Neurology; 95(24):e3232-e3240.  

MotherToBaby cuenta con el apoyo de la Administración de Recursos y Servicios de Salud (HRSA) del Departamento de Salud y Servicios Humanos de los Estados Unidos (HHS) como parte de una adjudicación por un total de $6,000,000 con cero porcentaje financiado con fuentes no gubernamentales. Los contenidos son los del autor/es y no representan necesariamente los puntos de vista oficiales de, ni un respaldo, por HRSA, HHS o el Gobierno de los Estados Unidos.