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

Joan D Garey; Per Damkier; Anthony R Scialli; Shari Lusskin; Stephen R Braddock; Laurent Chouchana; Brian Cleary; Elizabeth A Conover; Orna Diav-Citrin; Rachel S Dragovich; Facundo Garcia-Bournissen; Ken Hodson; Debra Kennedy; Steven H Lamm; Sharon A Lavigne; Sarah G Običan; Alice Panchaud; Kirstie Perrotta; Alfred N Romeo; Svetlana Shechtman; Corinna Weber-Schoendorfer

doi:10.1002/bdr2.2392

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

Joan D Garey
, Per Damkier
, Anthony R Scialli
, Shari Lusskin
, Stephen R Braddock
, Laurent Chouchana
, Brian Cleary
, Elizabeth A Conover
, Orna Diav-Citrin
, Rachel S Dragovich
, Facundo Garcia-Bournissen
, Ken Hodson
, Debra Kennedy
, Steven H Lamm
, Sharon A Lavigne
, Sarah G Običan
, Alice Panchaud
, Kirstie Perrotta
, Alfred N Romeo
, Svetlana Shechtman

Corinna Weber-Schoendorfer

Research output: Contribution to journal › Article › peer-review

8 Scopus citations

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.

Original language	English
Article number	e2392
Journal	Birth Defects Research
Volume	116
Issue number	8
DOIs	https://doi.org/10.1002/bdr2.2392
State	Published - Aug 2024
Externally published	Yes

Keywords

lamotrigine
levetiracetam
neurodevelopmental disorders
paternal valproate
valproate

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10.1002/bdr2.2392

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Garey, JD., Damkier, P., Scialli, AR., Lusskin, S., Braddock, SR., Chouchana, L., Cleary, B., Conover, EA., Diav-Citrin, O., Dragovich, RS., Garcia-Bournissen, F., Hodson, K., Kennedy, D., Lamm, SH., Lavigne, SA., Običan, SG., Panchaud, A., Perrotta, K., Romeo, AN., ... Weber-Schoendorfer, C. (2024). Paternal Valproate Treatment and Risk of Childhood Neurodevelopmental Disorders: Precautionary Regulatory Measures Are Insufficiently Substantiated. Birth Defects Research, 116(8), Article e2392. https://doi.org/10.1002/bdr2.2392

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

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 = "lamotrigine, levetiracetam, neurodevelopmental disorders, paternal valproate, valproate",

author = "Joan D Garey and Per Damkier and Anthony R Scialli and Shari Lusskin and Stephen R Braddock and Laurent Chouchana and Brian Cleary and Elizabeth A Conover and Orna Diav-Citrin and Rachel S Dragovich and Facundo Garcia-Bournissen and Ken Hodson and Debra Kennedy and Steven H Lamm and Sharon A Lavigne and Sarah G Obi{\v c}an and Alice Panchaud and Kirstie Perrotta and Alfred N Romeo and Svetlana Shechtman and Corinna Weber-Schoendorfer",

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year = "2024",

month = aug,

doi = "10.1002/bdr2.2392",

language = "English",

volume = "116",

journal = "Birth Defects Research",

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Garey, JD, Damkier, P, Scialli, AR, Lusskin, S, Braddock, SR, Chouchana, L, Cleary, B, Conover, EA, Diav-Citrin, O, Dragovich, RS, Garcia-Bournissen, F, Hodson, K, Kennedy, D, Lamm, SH, Lavigne, SA, Običan, SG, Panchaud, A, Perrotta, K, Romeo, AN, Shechtman, S & Weber-Schoendorfer, C 2024, 'Paternal Valproate Treatment and Risk of Childhood Neurodevelopmental Disorders: Precautionary Regulatory Measures Are Insufficiently Substantiated', Birth Defects Research, vol. 116, no. 8, e2392. https://doi.org/10.1002/bdr2.2392

TY - JOUR

T1 - Paternal Valproate Treatment and Risk of Childhood Neurodevelopmental Disorders

T2 - Precautionary Regulatory Measures Are Insufficiently Substantiated

AU - Garey, Joan D

AU - Damkier, Per

AU - Scialli, Anthony R

AU - Lusskin, Shari

AU - Braddock, Stephen R

AU - Chouchana, Laurent

AU - Cleary, Brian

AU - Conover, Elizabeth A

AU - Diav-Citrin, Orna

AU - Dragovich, Rachel S

AU - Garcia-Bournissen, Facundo

AU - Hodson, Ken

AU - Kennedy, Debra

AU - Lamm, Steven H

AU - Lavigne, Sharon A

AU - Običan, Sarah G

AU - Panchaud, Alice

AU - Perrotta, Kirstie

AU - Romeo, Alfred N

AU - Shechtman, Svetlana

AU - Weber-Schoendorfer, Corinna

PY - 2024/8

Y1 - 2024/8

N2 - 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.

AB - 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.

KW - lamotrigine

KW - levetiracetam

KW - neurodevelopmental disorders

KW - paternal valproate

KW - valproate

UR - https://www.scopus.com/pages/publications/85202064071

U2 - 10.1002/bdr2.2392

DO - 10.1002/bdr2.2392

M3 - Article

AN - SCOPUS:85202064071

SN - 2472-1727

VL - 116

JO - Birth Defects Research

JF - Birth Defects Research

IS - 8

M1 - e2392

ER -

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

Abstract

Keywords

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