Estimated Incidence of Sugammadex-Induced Anaphylaxis Using the Korea Adverse Event Reporting System Database.

Jae-Woo Ju,Ho-Jin Lee,Nayoung Kim,Won Ho Kim,Seong Mi Yang

doi:10.3390/jcm10153202

Abstract

We aimed to investigate the incidence of sugammadex-induced anaphylaxis in a large Korean population. We retrospectively investigated the incidence of sugammadex-induced anaphylaxis between 2013 and 2019 from the database of the Korea Institute of Drug Safety-Risk Management-Korea Adverse Event Reporting System (KIDS-KAERS). We estimated the incidence of sugammadex-induced anaphylaxis from the KIDS-KAERS database, assuming that the reporting efficiency was 10%, 50%, and 100%, respectively. We also investigated its annual sales volume in Korea and assumed that the exposure to sugammadex was 95% of the estimated sales volume. During the study period, 1,401,630 sugammadex vials were sold, and 19 cases of sugammadex-induced anaphylaxis were identified in the KIDS-KAERS database. The estimated incidence of sugammadex-induced anaphylaxis was 0.0143%, 0.00279%, and 0.0014%, assuming a reporting efficiency of 10%, 50%, and 100%, respectively. All patients, except for one with a missing record, fully recovered after anaphylaxis. The incidence of sugammadex-induced anaphylaxis identified in the national pharmacovigilance database was lower than previously reported rates in other countries. Therefore, its use in general anesthesia should not be hindered by concerns about the resulting risk of anaphylaxis in Korea.

Highlights

Sugammadex is associated with faster neuromuscular recovery, a lower rate of residual neuromuscular blockade [2], a lower incidence of major pulmonary complications [3], and earlier first bowel movement after surgery [4], compared to anticholinesterase inhibitors, which are conventional neuromuscular blocking agents (NMBAs) reversal agents
We investigated the nationwide number of reported cases of sugammadex-induced anaphylaxis using the database of the Korea Institute of Drug Safety & Risk Management-Korea
We investigated the incidence of sugammadex-induced anaphylaxis in a tertiary teaching hospital in South Korea

Summary

Introduction

Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations. Sugammadex is a modified γ-cyclodextrin that reverses the effect of steroidal nondepolarizing neuromuscular blocking agents (NMBAs) by forming a sugammadex-NMBA complex at a ratio of 1:1 [1]. Sugammadex is associated with faster neuromuscular recovery, a lower rate of residual neuromuscular blockade [2], a lower incidence of major pulmonary complications [3], and earlier first bowel movement after surgery [4], compared to anticholinesterase inhibitors, which are conventional NMBA reversal agents. Reversal of neuromuscular blockade with sugammadex is associated with a lower incidence of

Objectives

Results

Conclusion