Paternal Valproate Treatment and Risk of Childhood Neurodevelopmental Disorders: Precautionary Regulatory Measures Are Insufficiently Substantiated.
Details
Serval ID
serval:BIB_C9C07484EC95
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Paternal Valproate Treatment and Risk of Childhood Neurodevelopmental Disorders: Precautionary Regulatory Measures Are Insufficiently Substantiated.
Journal
Birth defects research
ISSN
2472-1727 (Electronic)
Publication state
Published
Issued date
08/2024
Peer-reviewed
Oui
Volume
116
Number
8
Pages
e2392
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
Publication Status: ppublish
Abstract
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 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.
Keywords
Humans, Valproic Acid/adverse effects, Neurodevelopmental Disorders/prevention & control, Neurodevelopmental Disorders/chemically induced, Male, Child, Epilepsy/drug therapy, United Kingdom, Anticonvulsants/adverse effects, Anticonvulsants/therapeutic use, Female, lamotrigine, levetiracetam, neurodevelopmental disorders, paternal valproate, valproate
Pubmed
Web of science
Create date
30/08/2024 15:48
Last modification date
31/10/2024 7:13