Safety assessment of sildenafil use in neonates: a real-world data analysis based on the FDA adverse event reporting system (FAERS).

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Expert Opinion on Drug Safety Pub Date : 2024-10-01 Epub Date: 2024-07-22 DOI:10.1080/14740338.2024.2383710
Bo Wang, Jia Zhang, Rui Cheng
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Abstract

Background: The safety of neonatal sildenafil use remains uncertain. This study aimed to investigate adverse events (AEs) associated with sildenafil use in neonates.

Research design and methods: We collected data on AEs associated with sildenafil use in neonates from the US Food and Drug Administration Adverse Event Reporting System database, spanning from its inception of the database in 2004 to 2023. Disproportionality measures were employed to analyze the correlation between AEs and sildenafil.

Results: Sildenafil was identified as the primary suspect drug in 75 AE reports, involving 214 AEs. Three system organ classes, namely, eye disorders, hepatobiliary disorders, and vascular disorders were associated with sildenafil use. Six preferred terms, namely, flushing, retinopathy of prematurity, hyperbilirubinemia, pulmonary hemorrhage, hypotension, and diarrhea were associated with sildenafil use. Notably, hyperbilirubinemia and pulmonary hemorrhage were previously unreported AEs associated with sildenafil use.

Conclusion: The results highlight the ongoing uncertainty surrounding the safety of neonatal sildenafil use and provide vital support for risk monitoring and identification in neonates receiving sildenafil. Additionally, the study underscores the need for continuous safety surveillance in neonates treated with sildenafil and suggests further exploration of the precise causal relationships between AEs and sildenafil.

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新生儿使用西地那非的安全性评估:基于 FDA 不良事件报告系统 (FAERS) 的真实世界数据分析。
背景:新生儿使用西地那非的安全性仍不确定。本研究旨在调查与新生儿使用西地那非相关的不良事件(AEs):我们从美国食品和药物管理局不良事件报告系统数据库中收集了与新生儿使用西地那非相关的AEs数据,时间跨度为2004年数据库建立之初至2023年。结果显示,西地那非被确定为导致新生儿AE的主要药物:在75例AE报告中,西地那非被确定为主要可疑药物,涉及214例AE。三个系统器官类别,即眼部疾病、肝胆疾病和血管疾病与使用西地那非有关。六个首选术语,即潮红、早产儿视网膜病变、高胆红素血症、肺出血、低血压和腹泻与使用西地那非有关。值得注意的是,高胆红素血症和肺出血是以前未报告过的与使用西地那非有关的AE:研究结果凸显了新生儿使用西地那非安全性的不确定性,为新生儿使用西地那非的风险监测和识别提供了重要支持。此外,该研究还强调了对接受西地那非治疗的新生儿进行持续安全监测的必要性,并建议进一步探讨AE与西地那非之间的确切因果关系。
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来源期刊
CiteScore
5.90
自引率
3.20%
发文量
97
审稿时长
6-12 weeks
期刊介绍: Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.
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