Systematic analysis of sugammadex-related adverse drug reaction signals using FAERS database

苏伽马德克斯 医学 不良事件报告系统 不利影响 医学名词 上市后监督 过敏反应 麻醉 重症监护医学 数据库 药物警戒 罗库溴铵 内科学 过敏 插管 计算机科学 免疫学
作者
Hongtao Liu,Qianqian Yang,Zhaoyu Li,Su Yan,Shaopeng Ming
出处
期刊:International Journal of Surgery [Elsevier]
标识
DOI:10.1097/js9.0000000000002194
摘要

Background: With the clinical integration of sugammadex, a selective relaxant-binding agent, the approach to reversing neuromuscular blockade is revolutionized. Despite its efficacy, sugammadex’s adverse reactions range from mild symptoms to severe cases, including anaphylaxis and coagulopathy. Assessing the nature of these reactions using the Food and Drug Administration’s Adverse Event Reporting System (FAERS) database is vital for safe anesthetic practice. This study aimed to analyze and categorize the adverse drug events (ADEs) related to sugammadex reported in the FAERS database and evaluate the potential safety signals since its market entry. Materials and Methods: This systematic analysis study extracted and filtered FAERS data pertinent to sugammadex from its introduction in 2008 to the last quarter of 2023 and employed standardized MedDRA terminologies for ADE re-encoding. The Reporting Odds Ratio (ROR) method analyzed ADE signal strength, identifying significant cardiovascular, allergic, and neurological signals. Results: From 1,505 patient reports totaling 3,562 ADEs, prominent adverse reaction signals were detected for respiratory and cardiovascular systems and severe allergic and neurological effects. Specific signals, including laryngospasm, bronchospasm, and Disseminated Intravascular Coagulation (DIC), among others, were highlighted and necessitated urgent clinical attention. Conclusions: Sugammadex is associated with a spectrum of adverse reactions, some of which demand increased clinical surveillance, particularly in older and pediatric populations. The significance of allergic reactions, airway spasms, and coagulation events indicates the need for precise risk assessment and vigilant monitoring during clinical use.

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