父亲的瓦尔酸治疗和儿童神经发育障碍的风险:预防性监管措施缺乏充分的证据
Joan D Garey1, Per Damkier2,3, Anthony R Scialli1
1Reproductive Toxicology Center, A Non-Profit Foundation, Washington, DC, USA.
Birth defects research
|August 27, 2024
概括
欧洲和英国的药物管理局发布了关于氨酸风险的过早警告. 专家认为,目前的数据不支持在暴露于氨酸的儿童中发生神经发育障碍的父性中介风险.
科学领域:
- 药物监督 药物监督 药物监督
- 生殖毒理学 生殖毒理学
- 神经发育障碍 神经发育障碍
背景情况:
- 欧洲药品管理局 (EMA) 和英国药品和医疗保健产品监管局 (MHRA) 最近的建议建议在使用酸时采取预防措施.
- 这些措施是基于对接受氨酸治疗的男性生育的儿童中神经发育障碍的潜在风险.
研究的目的:
- 评估EMA和MHRA关于父亲氨酸暴露的预防性建议的科学基础.
- 评估与氨酸相关的神经发育障碍的父亲介导风险的证据.
主要方法:
- 对酸的现有科学文献和数据进行审查和批判性分析.
- 来自欧洲病学信息服务网络 (ENTIS) 和病学信息专家组织 (OTIS) 成员的专家意见.
主要成果:
- 现有的科学数据并没有令人信服地支持推断父亲介导风险的推断.
- 证据不足以证明监管机构推的严格预防措施是合理的.
结论:
- 关于父亲使用氨酸的EMA和MHRA警告被认为是过早的.
- 在实施广泛的,严格的处方指南之前,需要进一步的强有力的科学证据.
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