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Abstract

Objective

To 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).

Methods

This 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).

Results

The 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.

Conclusions

These 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.

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Prenatal AED Exposure and Major Congenital Malformations

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Letters to the Editor

Information & Authors

Information

Published In

Neurology®
Volume 93Number 2July 9, 2019
Pages: e167-e180
PubMed: 31189695

Publication History

Received: September 28, 2018
Accepted: February 27, 2019
Published online: June 12, 2019
Published in print: July 9, 2019

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Study Funding

The authors are employees of the French National Health Insurance (CNAM), the French National Agency for Medicines and Health Products Safety (ANSM), the French Public Health Agency or work at CHU Est Parisien, CHU Rennes, or CHU Clermont-Ferrand and received no funding.

Authors

Affiliations & Disclosures

Pierre-Olivier Blotière, MSc https://orcid.org/0000-0002-6857-6781
From 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.
Disclosure
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NONE
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1.
NONE
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1.
NONE
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NONE
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1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
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1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
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1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
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1.
NONE
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1.
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Fanny Raguideau, PharmD
From 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.
Disclosure
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NONE
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1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
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1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
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Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
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Research Support, Government Entities:
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Research Support, Academic Entities:
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From 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.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
I am salaried by the French national health insurance (CNAM)
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
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1.
NONE
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Elisabeth Elefant, MD
From 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.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
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1.
NONE
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Isabelle Perthus, MD
From 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.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
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Véronique Goulet, MD, PhD
From 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.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
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1.
NONE
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1.
NONE
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1.
NONE
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NONE
Florence Rouget, MD
From 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.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Mahmoud Zureik, MD, PhD
From 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.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Joël Coste, MD, PhD
From 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.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE
Rosemary Dray-Spira, MD, PhD
From 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.
Disclosure
Scientific Advisory Boards:
1.
NONE
Gifts:
1.
NONE
Funding for Travel or Speaker Honoraria:
1.
NONE
Editorial Boards:
1.
NONE
Patents:
1.
NONE
Publishing Royalties:
1.
NONE
Employment, Commercial Entity:
1.
NONE
Consultancies:
1.
NONE
Speakers' Bureaus:
1.
NONE
Other Activities:
1.
NONE
Clinical Procedures or Imaging Studies:
1.
NONE
Research Support, Commercial Entities:
1.
NONE
Research Support, Government Entities:
1.
NONE
Research Support, Academic Entities:
1.
NONE
Research Support, Foundations and Societies:
1.
NONE
Stock/stock Options/board of Directors Compensation:
1.
NONE
License Fee Payments, Technology or Inventions:
1.
NONE
Royalty Payments, Technology or Inventions:
1.
NONE
Stock/stock Options, Research Sponsor:
1.
NONE
Stock/stock Options, Medical Equipment & Materials:
1.
NONE
Legal Proceedings:
1.
NONE

Notes

Correspondence Pierre-Olivier Blotière [email protected]
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
Parts of this work have previously been presented at the 33rd International Conference on Pharmacoepidemiology and Therapeutic Risk Management in Montreal, Canada (August 2017), and at the European Drug Utilisation Research Group Conference in Glasgow, UK (November 2017).

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