埃尔特罗姆博帕格
罗米普洛斯蒂姆
医学
不利影响
药物警戒
免疫性血小板减少症
不良事件报告系统
数据库
血小板生成素受体
儿科
内科学
血小板生成素
干细胞
造血
血小板
生物
遗传学
计算机科学
作者
Qiongtong Fang,Fuqiang Huang,Jiabi Liang,Yishen Chen,Cheng Li,Meirong Zhang,Xinrong Wu,Wenji Luo
标识
DOI:10.1080/14740338.2023.2182288
摘要
Background Romiplostim and eltrombopag are thrombopoietin receptor agonists (TPORAs) that have been approved by the FDA on 22 August 2008 and 20 November 2008 for pediatric immune thrombocytopenia (ITP). However, postmarketing pharmacovigilance of TPORAs in children still attracts much attention. We aimed to evaluate the safety of the TPORAs romiplostim and eltrombopag using data from the Adverse Event Reporting System database of FDA (FAERS).Research design and methods We conducted a disproportionality analysis and analyzed data from the FAERS database to characterize the key features of adverse events (AEs) associated with TPO-RAs approved for children under 18 years of age.Results Since their approval in the market in 2008, 250 and 298 reports of romiplostim and eltrombopag use in children have been published in the FAERS database, respectively. The most frequent AE associated with romiplostim and eltrombopag was epistaxis. Neutralizing antibodies and vitreous opacities showed the strongest signals for romiplostim and eltrombopag, respectively.Conclusions The labeled AEs for romiplostim and eltrombopag in children were analyzed. Unlabeled AEs may reflect the potential of new clinical individuals. Early recognition and management of AEs that appear in children treated with romiplostim and eltrombopag are of key importance in clinical practice.
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