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

被引：3

作者：

Garey, Joan D. ^{[1
]}

Damkier, Per ^{[2
,3
]}

Scialli, Anthony R. ^{[1
]}

Lusskin, Shari ^{[4
]}

Braddock, Stephen R. ^{[5
]}

Chouchana, Laurent ^{[6
]}

Cleary, Brian ^{[7
,8
]}

Conover, Elizabeth A. ^{[9
]}

Diav-Citrin, Orna ^{[10
,11
]}

Dragovich, Rachel S. ^{[12
]}

Garcia-Bournissen, Facundo ^{[13
]}

Hodson, Ken ^{[14
]}

Kennedy, Debra ^{[15
]}

Lamm, Steven H. ^{[16
]}

Lavigne, Sharon A. ^{[17
]}

Obican, Sarah G. ^{[18
]}

Panchaud, Alice ^{[19
,20
,21
]}

Perrotta, Kirstie ^{[22
]}

Romeo, Alfred N. ^{[23
]}

Shechtman, Svetlana ^{[10
]}

Weber-Schoendorfer, Corinna ^{[24
]}

机构：

[1] Nonprofit Fdn, Reprod Toxicol Ctr, Washington, DC 20016 USA

[2] Univ Southern Denmark, Dept Clin Res, Odense, Denmark

[3] Odense Univ Hosp, Dept Clin Pharmacol, Odense, Denmark

[4] St Louis Univ, Sch Med, Dept Pediat, Div Med Genet, St Louis, MO USA

[5] Cochin Port Royal Hosp, APHP, Reg Ctr Pharmacovigilance, Dept Pharmacol, Paris, France

[6] Rotunda Hosp, Dublin, Ireland

[7] Royal Coll Surgeons Ireland, Sch Pharm & Biomed Sci, Dublin, Ireland

[8] Icahn Sch Med Mt Sinai, Dept Psychiat & Obstet Gynecol & Reprod Sci, New York, NY USA

[9] Univ Nebraska Med Ctr, Munroe Meyer Inst, Div Clin Genet, Omaha, NE USA

[10] Minist Hlth, Israeli Teratol Informat Serv, Jerusalem, Israel

[11] Hebrew Univ Jerusalem, Hadassah Med Sch, Jerusalem, Israel

[12] Northeast Ohio Med Univ, Dept Internal Med, Rootstown, OH USA

[13] Western Univ, Schulich Sch Med & Dent, Dept Paediat, London, ON, Canada

[14] UK Teratol Informat Serv, Newcastle Upon Tyne, England

[15] Royal Hosp Women, Randwick, NSW, Australia

[16] Ctr Epidemiol & Maternal Child Hlth CEOH, Washington, DC USA

[17] UConn Hlth, Div Med Genet, MotherToBaby Connecticut, Farmington, CT USA

[18] Univ S Florida, Morsani Coll Med, Dept Obstet & Gynecol, Tampa, FL USA

[19] Univ Bern, Inst Primary Hlth Care BIHAM, Bern, Switzerland

[20] Lausanne Univ Hosp, Serv Pharm, Lausanne, Switzerland

[21] Univ Lausanne, Lausanne, Switzerland

[22] Univ Calif San Diego, Dept Pediat, La Jolla, CA USA

[23] Utah Dept Hlth, MotherToBaby Utah, Salt Lake City, UT USA

[24] Charite Univ Med Berlin, Inst Klin Pharmakol & Toxikol, Pharmakovigilanzzentrum Embryonaltoxikol, Berlin, Germany

来源：

BIRTH DEFECTS RESEARCH | 2024年 / 116卷 / 08期

关键词：

lamotrigine; levetiracetam; neurodevelopmental disorders; paternal valproate; valproate; EPILEPSY;

D O I：

10.1002/bdr2.2392

中图分类号：

Q [生物科学];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

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.

引用

页数：3

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