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• Alvarez I, et al. 2025. Breastfed infants exposed to lamotrigine faced a low risk of toxic effects. Acta Paediatr. 114(2):346-354. doi:10.1111/apa.17432 
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• An K, Xu J, Xi Y, et al. 2026. Analysis of ASMs and male infertility using the FDA adverse event reporting system (FAERS). Front Public Health. 13:1738546. 
• Arfman IJ, et al. 2020. Therapeutic drug monitoring of antiepileptic drugs in women with epilepsy before, during, and after pregnancy. Clin Pharmacokinet, 59(4):427-445.  
• Asranna A, et al. 2018.  Do anti-epileptic drug modifications after first trimester of pregnancy influence fetal malformation or cognitive outcome? Epilepsy Research, 146: 121-125. 
• Ban L, et al.  2015. Congenital anomalies in children of mothers taking antiepileptic drugs with and without periconceptional high dose folic acid use: a population-based cohort study. PLoS One, 10(7): e0131130. 
• Battino D, et al. 2024. Risk of Major Congenital Malformations and Exposure to Antiseizure Medication Monotherapy. JAMA Neurology. doi:10.1001/jamaneurol.2024.0258. 
• Bech LF, et al. 2018. In utero exposure to antiepileptic drugs is associated with learning disabilities among offspring. Journal of Neurology, Neurosurgery & Psychiatry, 89(12): 1324-1331. 
• Berry-Noronha A, et al. 2025. Risk of adverse pregnancy outcomes associated with antiseizure medications and their indications: A systematic review and meta-analysis. Neurology. 104(3):e210233.  
• Birnbaum AK, et al. 2020. Antiepileptic drug exposure in infants of breastfeeding mothers with epilepsy. JAMA Neurology, 77(4): 441-450. 
• Bjork MH, et al. 2022. Association of prenatal exposure to antiseizure medication with low risk of autism and intellectual disability. JAMA Neurology, 79(7)672-681. 
• Blotière PO, et al. 2019. Risks of 23 specific malformations associated with prenatal exposure to 10 antiepileptic drugs. Neurology, 93(2):e167-e180. 
• Borthen I. 2015. Obstetrical complications in women with epilepsy. Seizure, 28: 32-34. 
• Bromley RL, et al. 2013. The prevalence of neurodevelopmental disorders in children prenatally exposed to antiepileptic drugs. Journal of Neurology, Neurosurgery & Psychiatry, 84(6): 637-643. 
• Bromley RL, et al. 2018. Fetal antiepileptic drug exposure and cognitive outcomes. Seizure, 44:225–231. 
• Bromley R, et al. 2022. Monotherapy treatment of epilepsy in pregnancy: congenital malformation outcomes in the child. Cochrane Database of Systematic Reviews, 8(8):CD010224.  
• Bromley RL, et al. 2023. Neurodevelopment of babies born to mothers with epilepsy: a prospective observational cohort study. Epilepsia, 64:2454-2471. 
• Christensen J, et al, 2024. Dreier JW. Prenatal exposure to antiseizure medications and fetal growth: a population-based cohort study from the Nordic countries. Lancet Reg Health Eur. 38:100849. 
• Clark CT, Wisner KL. 2018. Treatment of Peripartum Bipolar Disorder. Obstet Gynecol Clin North Am, 45(3):403-417.  
• Cohen‐Israel M, et al. 2018. Short‐and long‐term complications of in utero exposure to lamotrigine. British Journal of Clinical Pharmacology, 84(1): 189-194. 
• Cohen JM, et al. 2019. Anticonvulsant mood stabilizer and lithium use and risk of adverse pregnancy outcomes. J Clin Psych, 80(4):18m12572.  
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• Jazayeri D, et al. 2018. Outcomes of pregnancies in women taking antiepileptic drugs for non-epilepsy indications. Seizure, 56: 111-114. 
• Kacirova I, et al. 2019. A short communication: lamotrigine levels in milk, mothers, and breastfed infants during the first postnatal month. Therapeutic Drug Monitoring, 41(3):401-404. 
• Kacirova I, et al. 2022. Monitoring of lamotrigine concentrations in mothers, colostrum, and breastfed newborns during the early postpartum period. Biomedicine and Pharmacolotherapy, 151:113167.  
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• Kohn E, et al. 2022. Magnitude of lamotrigine exposure through breastfeeding. Breastfeeding Medicine, 17(4):341-348.  
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• Kuczynska J, et al. 2019. Comparison of plasma, saliva, and hair lamotrigine concentrations. Clinical Biochemistry. 74:24-30. 
• Laspro M, et al. 2025. Association of commonly prescribed antepartum medications and incidence of orofacial Clefting. Cleft Palate Craniofac J. 62(7):1164-74 
• Larcin L, et al. 2024. Real-world assessment of psychotropic and antiepileptic drug use during pregnancy in Belgium: Trends, predictors, and comparative risk of congenital anomalies (2010-2016). Pharmacoepidemiol Drug Saf. 33(10):e70021.  
• Leutritz AL, et al. 2022. Psychotropic medication in pregnancy and lactation and development of exposed children. Br J Clin Pharmacol, 89(2):737-750.  
• Li X, et al. 2024. Drug-associated congenital anomalies of the external ear identified in the United States food and drug administration adverse event reporting system database. Scientific Rep. 14(1):23624. doi:10.1038/s41598-024-74744-3 
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• MacEachern DB, et al. 2019. Infertility, impaired fecundity, and live birth/pregnancy ratio in women with epilepsy in the USA: findings of the Epilepsy Birth Control Registry. Epilepsia, 60(9):1993-1998. 
• McVearry KM, et al. 2009. A prospective study of cognitive fluency and originality in children exposed in utero to carbamazepine, lamotrigine, or valproate monotherapy. Epilepsy Behav, 16(4):609-616. 
• Meador K, et al. 2011. Foetal antiepileptic drug exposure and verbal versus non-verbal abilities at three years of age. Brain, 134:396-404. 
• 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.  
• Meador KJ, et al. 2025. Neuropsychological outcomes in 6-year-old children of women with epilepsy: A prospective nonrandomized clinical trial. JAMA Neurology. 82(1):30-39.  
• Meng Q, et al. 2026. Prenatal exposure to antiseizure medications and risk of autism spectrum disorder in offspring: an integrated pharmacovigilance and two-sample mendelian randomization study. Epilepsy Res. 222:107756.  
• Montouris G, et al. 2005. Reproductive and sexual dysfunction in men with epilepsy. Epilepsy & Behavior, 7:7-14. 
• Mostacci B, et al. 2018. Emilia-Romagna study on pregnancy and exposure to antiepileptic drugs (ESPEA): a population-based study on prescription patterns, pregnancy outcomes and fetal health. J Neurol Neurosurg Psychiatry, 89:983–988. 
• Newport DJ, et al. 2008. Lamotrigine in breast milk and nursing infants: determination of exposure. Pediatrics, 122(1):e223-231. 
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• Pack AM, et al. 2025. Teratogenesis, perinatal, and neurodevelopmental outcomes after in utero exposure to antiseizure medication. Epilepsy curr. 15357597241258514.
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• Paulzen M, et al. 2015. Lamotrigine in pregnancy – therapeutic drug monitoring in maternal blood, amniotic fluid, and cord blood. Int Clin Psychopharmacol, 30(5):249-254. 
• Pekoz MT, et al. Birth outcomes in pregnant women with epilepsy: A nationwide multicenter study from Türkiye. Epilepsia, 64:2310-2321.  
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• Razaz N, et al. 2017. Association between pregnancy and perinatal outcomes among women with epilepsy. JAMA Neurology, 74(8):983-991. 
• Ren T, et al. 2023. Prenatal carbamazepine exposure and academic performance in adolescents: a population-based cohort study. Neurology, 100(7):e728-e738.  
• Richards N, et al. 2019. Developmental outcomes at age four following maternal antiepileptic drug use. Epilepsy & Behavior, 93:73-79. 
• Rihtman T, et al. 2013. Developmental outcomes at preschool age after fetal exposure to valproic acid and lamotrigine: cognitive, motor, sensory and behavioral function. Reprod Toxicol, 41:115–125. 
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• Schmidt CT, et al. 2023. Transfer of anticonvulsants and lithium into amniotic fluid, umbilical cord blood & breast milk: a systematic review & combined analysis. Prog Neuropsychopharmacol Biol Psychiatry, 124:110733.  
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• Thomas SV, et al. 2017. Malformation risk of antiepileptic drug exposure during pregnancy in women with epilepsy: results from a pregnancy registry in South India. Epilepsia, 58:274–281. 
• Thomas SV, et al. 2022. Differential impact of antenatal exposure to antiseizure medications on motor and mental development in infants of women with epilepsy. Discord, 24(3):531-540.  
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• 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. 
• Tomson T, et al. 2019. Declining malformation rates with changed antiepileptic drug prescribing: an observational study. Neurology, 93(9):e831-e840. 
• Vajda FJ, et al. 2013. Lamotrigine in epilepsy, pregnancy and psychiatry–a drug for all seasons? Journal of Clinical Neuroscience. 20(1):13-16. 
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• Vajda F, et al. 2025. Balancing foetal disadvantage and seizure freedom in women capable of pregnancy – the Australian pregnancy register experience. Epilepsy Behav. 172:110663. 
• Vajda FJ, et al. 2025. Is lamotrigine a teratogen? Seizure. 126:1-5. doi:10.1016/j.seizure.2025.01.019 
• Vajda FJE, et al. 2026. Lamotrigine as an antiseizure medication in pregnancy. Seizure. 136:18-22.  
• Veiby G, et al. 2013. Early child development and exposure to antiepileptic drugs prenatally and through breastfeeding: a prospective cohort study on children of women with epilepsy. JAMA Neurol, 70:1367-1374. 
• Veiby G, et al. 2015. Epilepsy and recommendations for breastfeeding. Seizure, 28:57-65. 
• Velez-Ruiz NJ, et al. 2015. Neurodevelopmental effects of fetal antiepileptic drug exposure. Drug Safety, 38(3): 271-278. 
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• Vieta E, et al. Lamotrigine efficacy, safety, and tolerability for women of childbearing age with bipolar disorder: meta-analysis from four randomized, placebo-controlled maintenance studies. European Neuropsychopharmacology, 78:81-92.   
• Wakil L, et al. 2009. Neonatal outcomes with the use of lamotrigine for bipolar disorder in pregnancy and breastfeeding: a case series and review of the literature. Psychopharmacol Bullb 42:91-98. 
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• Wiggs KK, et al. 2020. Antiseizure medication use during pregnancy and risk of ASD and ADHD in children. Neurology, 95;e3232-e3240.  
• Yeh TC, et al. 2021. Bipolar women’s antepartum psychotropic exposure and offspring risk of attention-deficit/hyperactivity disorder and autism spectrum disorder. Journal of Affective Disorders, 295:1407-1414.  
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• Zhao ZL, et al. 2025. Maternal exposure to lamotrigine and the risk of orofacial clefts in offspring: A systematic review and meta-analysis. Seizure. 131:67-72. doi:10.1016/j.seizure.2025.06.005. 

Selected References:

• Almgren M, et al. 2009. Population-based study of antiepileptic drug exposure in utero—influence on head circumference in newborns. Seizure 18(10):672-675. 
• Artama M, et al. 2013. Drug and Pregnancy Group: Effects of maternal epilepsy and antiepileptic drug use during pregnancy on perinatal health in offspring: nationwide, retrospective cohort study in Finland. Drug Saf 36(5):359-369.  
• 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. 
• Berry-Noronha A, et al. 2025. Risk of Adverse Pregnancy Outcomes Associated With Antiseizure Medications and Their Indications: A Systematic Review and Meta-Analysis. Neurology; 104(3):e210233 
• Bjork M-H, et al 2022. Association of prenatal exposure to antiseizure medication with risk of autism and intellectual disability. JAMA Neurol. Jul 1;79(7): 727. 
• Brandlistuen RE, et al. 2017. Association of prenatal exposure to benzodiazepines and child internalizing problems: A sibling-controlled cohort study. PLoS ONE 12(7): e0181042. 
• Cohn DF, et al. 1982. The effect of anticonvulsant drugs on the development of male rats and their fertility. J Neurol Neurosurg Psychiatry; 45(9):844-6.   
• Christensen et al. 2013.  Prenatal valproate exposure and risk of autism spectrum disorders and childhood autism. JAMA 309(16):1696-703.  
• Christensen J, et al. 2024. Prenatal exposure to antiseizure medications and fetal growth: a population-based cohort study from the Nordic countries. Lancet Reg Health Eur; 38:100849 
• Clonazepam. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017533s055lbl.pdf. Revised 2016. Accessed February 2026. 
• Daugaard C, 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. 
• Kallen B, et al. 2013. The use of central nervous system active drugs during pregnancy. Pharmaceuticals 6(10):1221-1286. 
• Kilic D, et al. 2014. Birth outcomes after prenatal exposure to antiepileptic drugs–a population-based study. Epilepsia 55(11):1714-1721.  
• Lin, A, et al. 2004. Clonazepam use in pregnancy and the risk of malformations. Birth Defects Res A Clin Mol Teratol 70(8):534-536. 
• Oberlander TF, et al. 2004. Pharmacologic factors associated with transient neonatal symptoms following prenatal psychotropic medication exposure. J Clin Psychiatry 65(2):230-237.  
• Soussan C. et al. 2014 Drug-induced adverse reactions via breastfeeding: a descriptive study in the French Pharmacovigilance Database. Eur J Clin Pharmacol. 70:1361-6. 
• Vajda FJE, et al. 2014. The teratogenicity of the newer antiepileptic drugs – an update. Acta Neurol Scand 130(4):234-238. 
• Veiby G, et al. 2014. Fetal growth restriction and birth defects with newer and older antiepileptic drugs during pregnancy. J Neurol 261(3):579-588.  
• Veiby G, et al. 2015. Epilepsy and recommendations for breastfeeding. Seizure 28:57-65. 
• Veroniki, AA, et al. 2017. Comparative safety of antiepileptic drugs for neurological development in children exposed during pregnancy and breast feeding: a systematic review and network meta-analysis. BMJ Open 7(7):e017248. 
• Weinstock L, et al. 2001. Obstetrical and neonatal outcome following clonazepam use during pregnancy: a case series. Psychother Psychosom 70(3):158-162. 

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• Dornelles AD, et al. 2014. Breastfeeding in Gaucher disease: is enzyme replacement therapy safe? Clin Ther; 36(6):990-1.  
• Elstein Y, et al. 2004. Pregnancies in Gaucher disease: a 5-year study. Am J Obstet Gynecol; 190:435–41. 
• Giannubilo SR, et al. 2015. Replacement Therapy for Gaucher Disease during Pregnancy: A Case Report. J Reprod Infertil;16(1):53-7.  
• Giraldo P, et al. 2021. Novel Management and Screening Approaches for Haematological Complications of Gaucher’s Disease. J Blood Med; 12:1045-1056.  
• Granovsky-Grisaru S, et al. 2011. The management of pregnancy in Gaucher disease. Eur I Obstet Gynecol Reprod Biol. 156: (1) 3-8. 
• Hughes DA, Pastores GM. 2000 [Updated December 7, 2023]. GeneReviews: Gaucher Disease. Available from: https://www.ncbi.nlm.nih.gov/books/NBK1269/. Accessed 12/2023. 
• Komninaka, V, et al. 2020. Outcomes of pregnancies in patients with Gaucher Disease: The experience of a center of excellence on rare metabolic Disease-Gaucher Disease, in Greece. Eur J Obstet Gynecol Reprod Biol; 254: 181-187. doi:10.1016/j.ejogrb.2020.09.027 
• Lau H, et al. 2018. Reported outcomes of 453 pregnancies in patients with Gaucher disease: An analysis from the Gaucher outcome survey. Blood Cells Mol Dis; 68:226-231. 
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