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

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.

REVersal of nEuromusculAr bLocking Agents in Patients Undergoing General Anaesthesia (REVEAL Study)

“…However, since its introduction, adverse effects have remained uncommon and comparable to those associated with other NMBA reversals. In a recent article published by Ju et al [ 32 ], the estimated incidence of sugammadex-induced anaphylaxis was 0.0014%. Furthermore, compared to neostigmine, sugammadex appears to have a decreased incidence of bradycardia in both children and adults [ 15 , 33 ].…”

Effects of sugammadex versus neostigmine on postoperative nausea and vomiting after general anesthesia in adult patients:a single-center retrospective study

“…Regression analysis also identified previously well-known predictors for PONV, supporting the reliability of our data. Additionally, considering the increasing use of sugammadex in our institution 14 , we only included patients from 2020 to minimize the effect of possible changes in perioperative management during the study period. A recent meta-analysis reported that compared with neostigmine, sugammadex was significantly associated with a reduction in PONV 15 .…”

“…Regression analysis also identified previously well-known predictors for PONV, supporting the reliability of our data. Additionally, considering the increasing use of sugammadex in our institution 14 , we only included patients from 2020 to minimize the effect of possible changes in perioperative Table 3. Interaction of primary and secondary outcomes between the use of sugammadex (vs neostigmine) and total intravenous anesthesia (vs inhalation anesthesia).…”

Effects of sugammadex versus neostigmine on postoperative nausea and vomiting in adult patients after general anesthesia: A single-center retrospective study

“…Regression analysis also revealed previously well-known predictors for PONV, supporting the reliability of our data. Additionally, considering the increasing use of sugammadex in our institution (Ju et al 2021), we only included patients from 2020 to minimize the effect of possible changes in perioperative management during the study period. A recent meta-analysis reported that compared with neostigmine, sugammadex was signi cantly associated with a reduction in PONV (Hurford et al 2020a).…”