{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T16:27:01Z","timestamp":1787243221545,"version":"build-2736575974"},"reference-count":9,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2024,8,27]],"date-time":"2024-08-27T00:00:00Z","timestamp":1724716800000},"content-version":"vor","delay-in-days":26,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Birth Defects Research"],"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>On January 12, 2024 the safety committee of the European Medicines Agency (EMA) recommended precautionary measures over a potential risk of neurodevelopmental disorders in children born to men treated with valproate. These new measures recommend patient supervision by a specialist in the management of epilepsy, bipolar disorder, or migraine. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a far more stringent precaution, warning against prescribing valproate to anyone under 55\u2009years of age. We, members of the European Network of Teratology Information Services (ENTIS) and the Organization of Teratology Information Specialists (OTIS), believe that the EMA and MHRA warnings were premature. We are of the opinion that the underlying scientific data do not convincingly substantiate the inference of a paternally mediated risk from valproate to children, much less to an extent that justifies these far\u2010reaching recommendations.<\/jats:p>","DOI":"10.1002\/bdr2.2392","type":"journal-article","created":{"date-parts":[[2024,8,27]],"date-time":"2024-08-27T07:40:34Z","timestamp":1724744434000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Paternal Valproate Treatment and Risk of Childhood Neurodevelopmental Disorders: Precautionary Regulatory Measures Are Insufficiently Substantiated"],"prefix":"10.1002","volume":"116","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9335-2173","authenticated-orcid":false,"given":"Joan D.","family":"Garey","sequence":"first","affiliation":[{"name":"Reproductive Toxicology Center, A Non\u2010Profit Foundation  Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0591-7187","authenticated-orcid":false,"given":"Per","family":"Damkier","sequence":"additional","affiliation":[{"name":"Department of Clinical Research University of Southern Denmark  Odense Denmark"},{"name":"Department of Clinical Pharmacology Odense University Hospital  Odense Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1351-4572","authenticated-orcid":false,"given":"Anthony R.","family":"Scialli","sequence":"additional","affiliation":[{"name":"Reproductive Toxicology Center, A Non\u2010Profit Foundation  Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shari","family":"Lusskin","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Obstetrics, Gynecology, and Reproductive Science Icahn School of Medicine at Mount Sinai  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen R.","family":"Braddock","sequence":"additional","affiliation":[{"name":"Division of Medical Genetics, Department of Pediatrics Saint Louis University School of Medicine  St. Louis Missouri USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Chouchana","sequence":"additional","affiliation":[{"name":"Regional Center of Pharmacovigilance, Department of Pharmacology Cochin Port Royal Hospital, APHP  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Cleary","sequence":"additional","affiliation":[{"name":"The Rotunda Hospital  Dublin Ireland"},{"name":"School of Pharmacy and Biomedical Sciences Royal College of Surgeons in Ireland  Dublin Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth A.","family":"Conover","sequence":"additional","affiliation":[{"name":"Division of Clinical Genetics Munroe Meyer Institute, University of Nebraska Medical Center  Omaha Nebraska USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7165-113X","authenticated-orcid":false,"given":"Orna","family":"Diav\u2010Citrin","sequence":"additional","affiliation":[{"name":"The Israeli Teratology Information Service Ministry of Health  Jerusalem Israel"},{"name":"The Hebrew University Hadassah Medical School  Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachel S.","family":"Dragovich","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Northeast Ohio Medical University  Rootstown Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Facundo","family":"Garcia\u2010Bournissen","sequence":"additional","affiliation":[{"name":"Department of Paediatrics Schulich School of Medicine and Dentistry, Western University  London Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ken","family":"Hodson","sequence":"additional","affiliation":[{"name":"UK Teratology Information Service  Newcastle upon Tyne UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Debra","family":"Kennedy","sequence":"additional","affiliation":[{"name":"Royal Hospital for Women  Randwick New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6764-0534","authenticated-orcid":false,"given":"Steven H.","family":"Lamm","sequence":"additional","affiliation":[{"name":"Center for Epidemiology and Maternal\u2010Child Health (CEOH)  Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sharon A.","family":"Lavigne","sequence":"additional","affiliation":[{"name":"MotherToBaby Connecticut, Division of Medical Genetics UConn Health  Farmington Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah G.","family":"Obi\u010dan","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Morsani College of Medicine, University of South Florida  Tampa Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alice","family":"Panchaud","sequence":"additional","affiliation":[{"name":"Institute of Primary Health Care (BIHAM), University of Bern  Bern Switzerland"},{"name":"Service of Pharmacy Lausanne University Hospital and University of Lausanne  Lausanne Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kirstie","family":"Perrotta","sequence":"additional","affiliation":[{"name":"Department of Pediatrics University of California, San Diego  La Jolla California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5478-386X","authenticated-orcid":false,"given":"Alfred N.","family":"Romeo","sequence":"additional","affiliation":[{"name":"MotherToBaby Utah, Utah Department of Health  Salt Lake City Utah USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Svetlana","family":"Shechtman","sequence":"additional","affiliation":[{"name":"The Israeli Teratology Information Service Ministry of Health  Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Corinna","family":"Weber\u2010Schoendorfer","sequence":"additional","affiliation":[{"name":"Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin, Pharmakovigilanzzentrum Embryonaltoxikologie, Institut f\u00fcr Klinische Pharmakologie und Toxikologie  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,8,27]]},"reference":[{"key":"e_1_2_4_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.biopsych.2017.08.006"},{"key":"e_1_2_4_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2024.14709"},{"key":"e_1_2_4_4_1","unstructured":"EMA.2024.\u201cPotential Risk of Neurodevelopmental Disorders in Children Born to Men Treated With Valproate Medicines: PRAC Recommends Precautionary Measures.\u201dhttps:\/\/www.ema.europa.eu\/en\/news\/potential\u2010risk\u2010neurodevelopmental\u2010disorders\u2010children\u2010born\u2010men\u2010treated\u2010valproate\u2010medicines\u2010prac\u2010recommends\u2010precautionary\u2010measures."},{"key":"e_1_2_4_5_1","unstructured":"MHRA.2024.\u201cValproate (Belvo Convulex Depakote Dyzantil Epilim Epilim Chrono or Chronosphere Episenta Epival and Syonell): New Safety and Educational Materials to Support Regulatory Measures in Men and Women Under 55\u2009Years of Age.\u201dhttps:\/\/www.gov.uk\/drug\u2010safety\u2010update\/valproate\u2010belvo\u2010convulex\u2010depakote\u2010dyzantil\u2010epilim\u2010epilim\u2010chrono\u2010or\u2010chronosphere\u2010episenta\u2010epival\u2010and\u2010syonellv\u2010new\u2010safety\u2010and\u2010educational\u2010materials\u2010to\u2010support\u2010regulatory\u2010measures\u2010in\u2010men\u2010and\u2010women\u2010under\u201055\u2010years\u2010of\u2010age."},{"key":"e_1_2_4_6_1","volume-title":"Advanced Topics in Environmental Health and air Pollution Case Studies","author":"Nicholich M. 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