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

IF 1.6 4区医学 Q4 DEVELOPMENTAL BIOLOGY

Birth Defects Research Pub Date : 2024-08-27 DOI:10.1002/bdr2.2392

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

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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.

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父亲丙戊酸钠治疗与儿童神经发育障碍的风险：预防性监管措施证据不足。

2024 年 1 月 12 日，欧洲药品管理局（EMA）安全委员会建议采取预防措施，以应对丙戊酸钠治疗男性所生子女出现神经发育障碍的潜在风险。这些新措施建议由癫痫、双相情感障碍或偏头痛治疗专家对患者进行监护。在英国，药品和保健品监管局（MHRA）发布了更为严格的预防措施，警告不要向 55 岁以下的任何人开丙戊酸钠处方。我们作为欧洲畸胎信息服务网络（ENTIS）和畸胎信息专家组织（OTIS）的成员，认为欧洲药品管理局和英国药品和保健品管理局的警告为时过早。我们认为，基本的科学数据并不能令人信服地证实丙戊酸钠对儿童的风险是由父亲介导的，更不能证明这些影响深远的建议是合理的。

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来源期刊

Birth Defects Research Medicine-Embryology

CiteScore

3.60

自引率

9.50%

发文量

153

期刊介绍： The journal Birth Defects Research publishes original research and reviews in areas related to the etiology of adverse developmental and reproductive outcome. In particular the journal is devoted to the publication of original scientific research that contributes to the understanding of the biology of embryonic development and the prenatal causative factors and mechanisms leading to adverse pregnancy outcomes, namely structural and functional birth defects, pregnancy loss, postnatal functional defects in the human population, and to the identification of prenatal factors and biological mechanisms that reduce these risks. Adverse reproductive and developmental outcomes may have genetic, environmental, nutritional or epigenetic causes. Accordingly, the journal Birth Defects Research takes an integrated, multidisciplinary approach in its organization and publication strategy. The journal Birth Defects Research contains separate sections for clinical and molecular teratology, developmental and reproductive toxicology, and reviews in developmental biology to acknowledge and accommodate the integrative nature of research in this field. Each section has a dedicated editor who is a leader in his/her field and who has full editorial authority in his/her area.