与丙戊酸相关的先天性斜视安全信号：利用 FDA 不良事件报告系统数据库进行药物警戒分析。

IF 1.3 4区医学 Q3 PEDIATRICS

Congenital Anomalies Pub Date : 2024-07-31 DOI:10.1111/cga.12579

Yuichi Uwai, Tomohiro Nabekura

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引用次数: 0

摘要

这项药物警戒研究利用 2014 年至 2023 年间美国食品药品管理局不良事件报告系统数据库，调查了抗癫痫药物与先天性斜视之间的关系。在 10 937 764 个病例的 28 347 889 份不良事件报告中，我们发现了 1104 份斜视报告和 67 份先天性斜视报告。丙戊酸是最常见的主要可疑药物（分别为 95 例和 14 例）。95例报告涉及经胎盘接触丙戊酸，信息成分（IC）为7.06（IC-2 × 标准差：5.50）。多变量分析显示，经胎盘接触丙戊酸与斜视有关（调整后的几率比：8.47，95% CI：6.74-10.65）。我们揭示了丙戊酸与先天性斜视相关的一个强有力的安全信号。

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A safety signal for congenital strabismus associated with valproic acid: A pharmacovigilance analysis utilizing the FDA Adverse Event Reporting System database

This pharmacovigilance study investigated the relationship between antiepileptic drugs and congenital strabismus, utilizing the FDA Adverse Event Report System database between 2014 and 2023. Out of 28 347 889 reports of adverse events in 10 937 764 cases, we identified 1104 reports of strabismus and 67 of congenital strabismus. Valproic acid was the most frequently implicated primary suspect drug (95 and 14 cases, respectively). Ninety-five reports involved transplacental valproic acid exposure, yielding an information component (IC) of 7.06 (IC-2 × standard deviation: 5.50). A multivariate analysis showed that transplacental exposure to valproic acid correlated with strabismus (adjusted odds ratio: 8.47, 95% CI: 6.74–10.65). We revealed a robust safety signal linking valproic acid to congenital strabismus.

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来源期刊

Congenital Anomalies PEDIATRICS-

自引率

0.00%

发文量

审稿时长

>12 weeks

期刊介绍： Congenital Anomalies is the official English language journal of the Japanese Teratology Society, and publishes original articles in laboratory as well as clinical research in all areas of abnormal development and related fields, from all over the world. Although contributions by members of the teratology societies affiliated with The International Federation of Teratology Societies are given priority, contributions from non-members are welcomed.