ArticleNeurology2019
Risks of 23 specific malformations associated with prenatal exposure to 10 antiepileptic drugs.
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Article in Neurology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 3 of them syntheses that pooled it.
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41citing papers in PubMed, 3 pooled it
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41 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Medication use during pregnancy and the risk of gastroschisis: a systematic review and meta-analysis of observational studies.Orphanet journal of rare diseases · 2024Pooled it
- Prenatal exposure to pregabalin, birth outcomes and neurodevelopment - a population-based cohort study in four Nordic countries.Drug safety · 2023Pooled it
- Neonatal outcomes after gamma-aminobutyric acid analog use during pregnancy: a meta-analysis of cohort studies.European journal of clinical pharmacology · 2022Pooled it
- Identification of major congenital malformations based on healthcare databases in France: A proof-of-concept study using the epi-meres nationwide mother-child register.British journal of clinical pharmacology · 2026Article
- Gabapentin and Pregabalin Use in First Trimester of Pregnancy and Risk of Specific Congenital Anomalies: An IMI ConcePTION European Case-Malformed Control Study.Drug safety · 2026Article
- Lacosamide Safety During Pregnancy and Breastfeeding: A Single-Centre Experience and Comprehensive Narrative Review.Pharmacy (Basel, Switzerland) · 2026Article
- Article
- Evaluation of the effects of prenatal exposure to pregabalin and postnatal analysis of dental and mandibular bone tissue development in rat offspring.Odontology · 2025Article
- Trends in Prenatal Exposure to Antiseizure Medications Over the Past Decade: A Nationwide Study.Neurology · 2025Article
- Pregabalin Safety in Pregnancy: A Disproportionality Analysis of VigiBase Spontaneous Reporting System.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Seizures in brain tumors: pathogenesis, risk factors and management (Review).International journal of molecular medicine · 2025Review
- First-trimester exposure to macrolides and risk of major congenital malformations compared with amoxicillin: A French nationwide cohort study.PLoS medicine · 2025Article
- High-Dose Cyproterone Acetate and Intracranial Meningioma: Impact of the Risk Minimisation Measures Implemented in France in 2018-2019.Pharmacoepidemiology and drug safety · 2025Article
- Pre- and Postnatal Valproate Exposure Affects Brain Development.Current topics in behavioral neurosciences · 2025Review
- The Safety of Alcohol Pharmacotherapies in Pregnancy: A Scoping Review of Human and Animal Research.CNS drugs · 2025Article
- The Association Between In Utero Exposure to Painkillers and Trajectories of Hyperactivity and Emotional Problems in Children with Autism Compared with Neurotypical Peers.Children (Basel, Switzerland) · 2024Article
- Mechanisms of neurodevelopmental toxicity of topiramate.Critical reviews in toxicology · 2024Review
- Valproate Use During Spermatogenesis and Risk to Offspring.JAMA network open · 2024Article
- Medically Assisted Reproduction and Risk of Cancer Among Offspring.JAMA network open · 2024Article
- Prenatal exposure to antiseizure medications and fetal growth: a population-based cohort study from the Nordic countries.The Lancet regional health. Europe · 2024Article
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Authors and funding
10 authors.
Pierre-Olivier BlotièreFrom the Department of Studies in Public Health (P.-O.B., A.W., J.C.), French National Health Insurance (CNAM), Paris; Université de Lorraine (P.-O.B.), Université Paris-Descartes, Apemac, Nancy; Department of Epidemiology of Health Products (F. Raguideau, M.Z., R.D.-S.), French National Agency for Medicines and Health Products Safety, Saint-Denis; Reference Center on Teratogenic Agents (E.E.), Hôpital Trousseau, Groupe Hospitalo-Universitaire Est Parisien, Assistance Publique Hôpitaux de Paris; Auvergne Registry of Congenital Malformations (I.P.), Centre de référence des Anomalies du Développement et des maladies rares, Service de génétique médicale, CHU Clermont-Ferrand; Department of Chronic Diseases and Injuries (V.G.), French Public Health Agency, Saint Maurice; Brittany Registry of Congenital Malformations (F. Rouget), Université de Rennes, CHU Rennes, Inserm, EHESP, Irset (Institut de recherche en santé, environnement et travail)-UMR_S 1085; Versailles Saint-Quentin University (M.Z.); and Biostatistics and Epidemiology Unit (J.C.), Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris, and Paris Descartes University, France. pierre-olivier.blotiere@assurance-maladie.fr.ORCID 0000-0002-6857-6781
Fanny RaguideauFrom the Department of Studies in Public Health (P.-O.B., A.W., J.C.), French National Health Insurance (CNAM), Paris; Université de Lorraine (P.-O.B.), Université Paris-Descartes, Apemac, Nancy; Department of Epidemiology of Health Products (F. Raguideau, M.Z., R.D.-S.), French National Agency for Medicines and Health Products Safety, Saint-Denis; Reference Center on Teratogenic Agents (E.E.), Hôpital Trousseau, Groupe Hospitalo-Universitaire Est Parisien, Assistance Publique Hôpitaux de Paris; Auvergne Registry of Congenital Malformations (I.P.), Centre de référence des Anomalies du Développement et des maladies rares, Service de génétique médicale, CHU Clermont-Ferrand; Department of Chronic Diseases and Injuries (V.G.), French Public Health Agency, Saint Maurice; Brittany Registry of Congenital Malformations (F. Rouget), Université de Rennes, CHU Rennes, Inserm, EHESP, Irset (Institut de recherche en santé, environnement et travail)-UMR_S 1085; Versailles Saint-Quentin University (M.Z.); and Biostatistics and Epidemiology Unit (J.C.), Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris, and Paris Descartes University, France.
Alain WeillFrom the Department of Studies in Public Health (P.-O.B., A.W., J.C.), French National Health Insurance (CNAM), Paris; Université de Lorraine (P.-O.B.), Université Paris-Descartes, Apemac, Nancy; Department of Epidemiology of Health Products (F. Raguideau, M.Z., R.D.-S.), French National Agency for Medicines and Health Products Safety, Saint-Denis; Reference Center on Teratogenic Agents (E.E.), Hôpital Trousseau, Groupe Hospitalo-Universitaire Est Parisien, Assistance Publique Hôpitaux de Paris; Auvergne Registry of Congenital Malformations (I.P.), Centre de référence des Anomalies du Développement et des maladies rares, Service de génétique médicale, CHU Clermont-Ferrand; Department of Chronic Diseases and Injuries (V.G.), French Public Health Agency, Saint Maurice; Brittany Registry of Congenital Malformations (F. Rouget), Université de Rennes, CHU Rennes, Inserm, EHESP, Irset (Institut de recherche en santé, environnement et travail)-UMR_S 1085; Versailles Saint-Quentin University (M.Z.); and Biostatistics and Epidemiology Unit (J.C.), Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris, and Paris Descartes University, France.ORCID 0000-0001-8687-9092
Elisabeth ElefantFrom the Department of Studies in Public Health (P.-O.B., A.W., J.C.), French National Health Insurance (CNAM), Paris; Université de Lorraine (P.-O.B.), Université Paris-Descartes, Apemac, Nancy; Department of Epidemiology of Health Products (F. Raguideau, M.Z., R.D.-S.), French National Agency for Medicines and Health Products Safety, Saint-Denis; Reference Center on Teratogenic Agents (E.E.), Hôpital Trousseau, Groupe Hospitalo-Universitaire Est Parisien, Assistance Publique Hôpitaux de Paris; Auvergne Registry of Congenital Malformations (I.P.), Centre de référence des Anomalies du Développement et des maladies rares, Service de génétique médicale, CHU Clermont-Ferrand; Department of Chronic Diseases and Injuries (V.G.), French Public Health Agency, Saint Maurice; Brittany Registry of Congenital Malformations (F. Rouget), Université de Rennes, CHU Rennes, Inserm, EHESP, Irset (Institut de recherche en santé, environnement et travail)-UMR_S 1085; Versailles Saint-Quentin University (M.Z.); and Biostatistics and Epidemiology Unit (J.C.), Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris, and Paris Descartes University, France.
Isabelle PerthusFrom the Department of Studies in Public Health (P.-O.B., A.W., J.C.), French National Health Insurance (CNAM), Paris; Université de Lorraine (P.-O.B.), Université Paris-Descartes, Apemac, Nancy; Department of Epidemiology of Health Products (F. Raguideau, M.Z., R.D.-S.), French National Agency for Medicines and Health Products Safety, Saint-Denis; Reference Center on Teratogenic Agents (E.E.), Hôpital Trousseau, Groupe Hospitalo-Universitaire Est Parisien, Assistance Publique Hôpitaux de Paris; Auvergne Registry of Congenital Malformations (I.P.), Centre de référence des Anomalies du Développement et des maladies rares, Service de génétique médicale, CHU Clermont-Ferrand; Department of Chronic Diseases and Injuries (V.G.), French Public Health Agency, Saint Maurice; Brittany Registry of Congenital Malformations (F. Rouget), Université de Rennes, CHU Rennes, Inserm, EHESP, Irset (Institut de recherche en santé, environnement et travail)-UMR_S 1085; Versailles Saint-Quentin University (M.Z.); and Biostatistics and Epidemiology Unit (J.C.), Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris, and Paris Descartes University, France.
Véronique GouletFrom the Department of Studies in Public Health (P.-O.B., A.W., J.C.), French National Health Insurance (CNAM), Paris; Université de Lorraine (P.-O.B.), Université Paris-Descartes, Apemac, Nancy; Department of Epidemiology of Health Products (F. Raguideau, M.Z., R.D.-S.), French National Agency for Medicines and Health Products Safety, Saint-Denis; Reference Center on Teratogenic Agents (E.E.), Hôpital Trousseau, Groupe Hospitalo-Universitaire Est Parisien, Assistance Publique Hôpitaux de Paris; Auvergne Registry of Congenital Malformations (I.P.), Centre de référence des Anomalies du Développement et des maladies rares, Service de génétique médicale, CHU Clermont-Ferrand; Department of Chronic Diseases and Injuries (V.G.), French Public Health Agency, Saint Maurice; Brittany Registry of Congenital Malformations (F. Rouget), Université de Rennes, CHU Rennes, Inserm, EHESP, Irset (Institut de recherche en santé, environnement et travail)-UMR_S 1085; Versailles Saint-Quentin University (M.Z.); and Biostatistics and Epidemiology Unit (J.C.), Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris, and Paris Descartes University, France.
Florence RougetFrom the Department of Studies in Public Health (P.-O.B., A.W., J.C.), French National Health Insurance (CNAM), Paris; Université de Lorraine (P.-O.B.), Université Paris-Descartes, Apemac, Nancy; Department of Epidemiology of Health Products (F. Raguideau, M.Z., R.D.-S.), French National Agency for Medicines and Health Products Safety, Saint-Denis; Reference Center on Teratogenic Agents (E.E.), Hôpital Trousseau, Groupe Hospitalo-Universitaire Est Parisien, Assistance Publique Hôpitaux de Paris; Auvergne Registry of Congenital Malformations (I.P.), Centre de référence des Anomalies du Développement et des maladies rares, Service de génétique médicale, CHU Clermont-Ferrand; Department of Chronic Diseases and Injuries (V.G.), French Public Health Agency, Saint Maurice; Brittany Registry of Congenital Malformations (F. Rouget), Université de Rennes, CHU Rennes, Inserm, EHESP, Irset (Institut de recherche en santé, environnement et travail)-UMR_S 1085; Versailles Saint-Quentin University (M.Z.); and Biostatistics and Epidemiology Unit (J.C.), Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris, and Paris Descartes University, France.
Mahmoud ZureikFrom the Department of Studies in Public Health (P.-O.B., A.W., J.C.), French National Health Insurance (CNAM), Paris; Université de Lorraine (P.-O.B.), Université Paris-Descartes, Apemac, Nancy; Department of Epidemiology of Health Products (F. Raguideau, M.Z., R.D.-S.), French National Agency for Medicines and Health Products Safety, Saint-Denis; Reference Center on Teratogenic Agents (E.E.), Hôpital Trousseau, Groupe Hospitalo-Universitaire Est Parisien, Assistance Publique Hôpitaux de Paris; Auvergne Registry of Congenital Malformations (I.P.), Centre de référence des Anomalies du Développement et des maladies rares, Service de génétique médicale, CHU Clermont-Ferrand; Department of Chronic Diseases and Injuries (V.G.), French Public Health Agency, Saint Maurice; Brittany Registry of Congenital Malformations (F. Rouget), Université de Rennes, CHU Rennes, Inserm, EHESP, Irset (Institut de recherche en santé, environnement et travail)-UMR_S 1085; Versailles Saint-Quentin University (M.Z.); and Biostatistics and Epidemiology Unit (J.C.), Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris, and Paris Descartes University, France.
Joël CosteFrom the Department of Studies in Public Health (P.-O.B., A.W., J.C.), French National Health Insurance (CNAM), Paris; Université de Lorraine (P.-O.B.), Université Paris-Descartes, Apemac, Nancy; Department of Epidemiology of Health Products (F. Raguideau, M.Z., R.D.-S.), French National Agency for Medicines and Health Products Safety, Saint-Denis; Reference Center on Teratogenic Agents (E.E.), Hôpital Trousseau, Groupe Hospitalo-Universitaire Est Parisien, Assistance Publique Hôpitaux de Paris; Auvergne Registry of Congenital Malformations (I.P.), Centre de référence des Anomalies du Développement et des maladies rares, Service de génétique médicale, CHU Clermont-Ferrand; Department of Chronic Diseases and Injuries (V.G.), French Public Health Agency, Saint Maurice; Brittany Registry of Congenital Malformations (F. Rouget), Université de Rennes, CHU Rennes, Inserm, EHESP, Irset (Institut de recherche en santé, environnement et travail)-UMR_S 1085; Versailles Saint-Quentin University (M.Z.); and Biostatistics and Epidemiology Unit (J.C.), Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris, and Paris Descartes University, France.
Rosemary Dray-SpiraFrom the Department of Studies in Public Health (P.-O.B., A.W., J.C.), French National Health Insurance (CNAM), Paris; Université de Lorraine (P.-O.B.), Université Paris-Descartes, Apemac, Nancy; Department of Epidemiology of Health Products (F. Raguideau, M.Z., R.D.-S.), French National Agency for Medicines and Health Products Safety, Saint-Denis; Reference Center on Teratogenic Agents (E.E.), Hôpital Trousseau, Groupe Hospitalo-Universitaire Est Parisien, Assistance Publique Hôpitaux de Paris; Auvergne Registry of Congenital Malformations (I.P.), Centre de référence des Anomalies du Développement et des maladies rares, Service de génétique médicale, CHU Clermont-Ferrand; Department of Chronic Diseases and Injuries (V.G.), French Public Health Agency, Saint Maurice; Brittany Registry of Congenital Malformations (F. Rouget), Université de Rennes, CHU Rennes, Inserm, EHESP, Irset (Institut de recherche en santé, environnement et travail)-UMR_S 1085; Versailles Saint-Quentin University (M.Z.); and Biostatistics and Epidemiology Unit (J.C.), Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris, and Paris Descartes University, France.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo assess the association between exposure to monotherapy with 10 different antiepileptic drugs (AEDs) during the first 2 months of pregnancy and the risk of 23 major congenital malformations (MCMs).
methodsThis nationwide cohort study, based on the French health care databases, included all pregnancies ≥20 weeks and ending between January 2011 and March 2015. Women were considered to be exposed when an AED had been dispensed between 1 month before and 2 months after the beginning of pregnancy. The reference group included pregnant women with no reimbursement for AEDs. MCMs were detected up to 12 months after birth (24 months for microcephaly, hypospadias, and epispadias). Odds ratios (ORs) were adjusted for potential confounders for MCMs with at least 5 cases. Otherwise, we calculated crude ORs with exact confidence intervals (CIs).
resultsThe cohort included 1,886,825 pregnancies, 2,997 of which were exposed to lamotrigine, 1,671 to pregabalin, 980 to clonazepam, 913 to valproic acid, 579 to levetiracetam, 517 to topiramate, 512 to carbamazepine, 365 to gabapentin, 139 to oxcarbazepine, and 80 to phenobarbital. Exposure to valproic acid was associated with 8 specific types of MCMs (e.g., spina bifida, OR 19.4, 95% CI 8.6-43.5), and exposure to topiramate was associated with an increased risk of cleft lip (6.8, 95% CI 1.4-20.0). We identified 3 other signals. We found no significant association for lamotrigine, levetiracetam, carbamazepine, oxcarbazepine, and gabapentin.
conclusionsThese results confirm the teratogenicity of valproic acid and topiramate. Because of the small numbers of cases and possible confounding, the other 3 signals should be interpreted with appropriate caution.
Indexed as
AdultAnticonvulsantsCohort StudiesCongenital AbnormalitiesFemaleFranceHumansInfant, NewbornMalePregnancyPregnancy Trimester, FirstPrenatal Exposure Delayed EffectsPrenatal InjuriesYoung AdultAnticonvulsants
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