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

Abstract

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 1505 patient reports totaling 3562 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.