Paternal Valproate Treatment and Risk of Childhood Neurodevelopmental Disorders: Precautionary Regulatory Measures Are Insufficiently Substantiated-Reference-Cited by-同舟云学术

Paternal Valproate Treatment and Risk of Childhood Neurodevelopmental Disorders: Precautionary Regulatory Measures Are Insufficiently Substantiated

Published:2024-08 Issue:8 Volume:116 Page:
ISSN:2472-1727
Container-title:Birth Defects Research
language:en
Short-container-title:Birth Defects Research

Author:

Garey Joan D.¹^ORCID,Damkier Per²³^ORCID,Scialli Anthony R.¹^ORCID,Lusskin Shari⁴,Braddock Stephen R.⁵,Chouchana Laurent⁶,Cleary Brian⁷⁸,Conover Elizabeth A.⁹,Diav‐Citrin Orna¹⁰¹¹^ORCID,Dragovich Rachel S.¹²,Garcia‐Bournissen Facundo¹³,Hodson Ken¹⁴,Kennedy Debra¹⁵,Lamm Steven H.¹⁶^ORCID,Lavigne Sharon A.¹⁷,Običan Sarah G.¹⁸,Panchaud Alice¹⁹²⁰,Perrotta Kirstie²¹,Romeo Alfred N.²²^ORCID,Shechtman Svetlana¹⁰,Weber‐Schoendorfer Corinna²³

Affiliation:

1. Reproductive Toxicology Center, A Non‐Profit Foundation Washington DC USA

2. Department of Clinical Research University of Southern Denmark Odense Denmark

3. Department of Clinical Pharmacology Odense University Hospital Odense Denmark

4. Division of Medical Genetics, Department of Pediatrics Saint Louis University School of Medicine St. Louis Missouri USA

5. Regional Center of Pharmacovigilance, Department of Pharmacology Cochin Port Royal Hospital, APHP Paris France

6. The Rotunda Hospital Dublin Ireland

7. School of Pharmacy and Biomedical Sciences Royal College of Surgeons in Ireland Dublin Ireland

8. Department of Psychiatry and Obstetrics, Gynecology, and Reproductive Science Icahn School of Medicine at Mount Sinai New York New York USA

9. Division of Clinical Genetics Munroe Meyer Institute, University of Nebraska Medical Center Omaha Nebraska USA

10. The Israeli Teratology Information Service Ministry of Health Jerusalem Israel

11. The Hebrew University Hadassah Medical School Jerusalem Israel

12. Department of Internal Medicine Northeast Ohio Medical University Rootstown Ohio USA

13. Department of Paediatrics Schulich School of Medicine and Dentistry, Western University London Ontario Canada

14. UK Teratology Information Service Newcastle upon Tyne UK

15. Royal Hospital for Women Randwick New South Wales Australia

16. Center for Epidemiology and Maternal‐Child Health (CEOH) Washington DC USA

17. MotherToBaby Connecticut, Division of Medical Genetics UConn Health Farmington Connecticut USA

18. Department of Obstetrics and Gynecology Morsani College of Medicine, University of South Florida Tampa Florida USA

19. Institute of Primary Health Care (BIHAM), University of Bern Bern Switzerland

20. Service of Pharmacy Lausanne University Hospital and University of Lausanne Lausanne Switzerland

21. Department of Pediatrics University of California, San Diego La Jolla California USA

22. MotherToBaby Utah, Utah Department of Health Salt Lake City Utah USA

23. Charité – Universitätsmedizin Berlin, Pharmakovigilanzzentrum Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie Berlin Germany

Abstract

ABSTRACTOn 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 years 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‐reaching recommendations.

Publisher

Wiley

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/bdr2.2392

Reference9 articles.

1. Familial Liability to Epilepsy and Attention-Deficit/Hyperactivity Disorder: A Nationwide Cohort Study

2. Valproate Use During Spermatogenesis and Risk to Offspring

3. EMA.2024.“Potential Risk of Neurodevelopmental Disorders in Children Born to Men Treated With Valproate Medicines: PRAC Recommends Precautionary Measures.”https://www.ema.europa.eu/en/news/potential‐risk‐neurodevelopmental‐disorders‐children‐born‐men‐treated‐valproate‐medicines‐prac‐recommends‐precautionary‐measures.

4. MHRA.2024.“Valproate (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 Years of Age.”https://www.gov.uk/drug‐safety‐update/valproate‐belvo‐convulex‐depakote‐dyzantil‐epilim‐epilim‐chrono‐or‐chronosphere‐episenta‐epival‐and‐syonellv‐new‐safety‐and‐educational‐materials‐to‐support‐regulatory‐measures‐in‐men‐and‐women‐under‐55‐years‐of‐age.