Incidence of Anaphylaxis to Sugammadex in a Single-Center Cohort of 19,821 Patients

Abstract

Background: Sugammadex is a modified cyclodextrin that is being increasingly used in anesthetic practice worldwide for the reversal of the aminosteroid neuromuscular blockers rocuronium and vecuronium. Its safety profile, however, is incompletely understood. One such aspect is the incidence of anaphylactic reactions that occur after its administration. While several case reports exist in the literature, there is a paucity of information on the actual incidence of anaphylactic reactions. METHODS: A single-center retrospective chart review identified patients who experienced anaphylaxis to sugammadex in the institutional electronic medical record system. These charts were then reviewed to determine whether the etiology of anaphylaxis was sugammadex administration. RESULTS: Two patients experienced anaphylaxis to sugammadex, which occurred in a single institution cohort of 19,821 patients who received 23,446 total doses. This rate is markedly lower than the 1/300 that the manufacturer’s package insert states and also lower than the 1/2500 that the only other large cohort study performed has reported. CONCLUSIONS: The incidence of anaphylaxis to sugammadex in this cohort of patients was 2 of 19,821 patients, who received a total of 23,446 doses.

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

“…To investigate the incidence of sugammadex-related anaphylaxis in our institution, we followed the protocol of a recently published study regarding sugammadex-induced anaphylaxis [ 12 ]. From the electronic medical records (EMR) database, we selected adult patients (aged ≥18 years) who underwent surgery under general anesthesia with the use of sugammadex for reversal of neuromuscular blockade at the end of the surgery, between January 2013 and December 2020.…”

“…In our institution, physicians and nurses can report previously known or current incidences of adverse drug events (ADEs) to the drug adverse reaction system in the EMR. Second, we searched for anesthetic records where both sugammadex and epinephrine were administered intravenously to the same patient [ 12 ].…”

“…Since then, the incidence of sugammadex-induced anaphylaxis in a large-scale population has been reported for a few countries, but not for South Korea [ 6 , 10 , 11 , 12 ]. According to the pharmacopoeia of sugammadex (Bridion ® , MSD, Seoul, Korea) in South Korea, no anaphylactic reaction has been reported in a post-marketing survey of 718 patients [ 13 ], and only a few case reports have been published in South Korea [ 14 , 15 , 16 , 17 , 18 ].…”

A Clinical and Budgetary Impact Analysis of Introducing Sugammadex for Routine Reversal of Neuromuscular Blockade in a Hypothetical Cohort in the US

“…In the product label of sugammadex, the incidence of anaphylaxis is reported at 0.3% (1 in 299 healthy volunteers; 16 mg/kg dose, only for NMB reversal soon after administration of a single dose of rocuronium) from a randomized clinical trial [32] in which participants were actively monitored. It is more rare in real-world settings, as passive surveillance, at far lower doses, across tens of millions of patient exposure has observed far fewer events [70][71][72], and its impact on the budget is likely to be negligible.…”

Sugammadex-Induced Anaphylaxis: 2 Case Reports

“…With the introduction of sugammadex in Japan in 2010, the Japanese society of anesthesiologists reported an incidence of hypersensitivity reactions of 0.0029% [4]. Later in 2019, with an epidemiological review based on a retrospective study with 15.479 patients the estimate was 0.0039% [5], and more recently in an American study with 19.821 patients, the rate of anaphylactic reactions was 0.0085% [6].…”