Anaphylactic shock after sugammadex administration, induced by formation of a sugammadex-rocuronium complex -a case report-

Kim, Gunn Hee; Choi, Won Seop; Kim, Ji Eun; Yun, Mi Jung; Koo, Min Seok; Kwon, MiYoung; Seo, Hyungseok

doi:10.4097/kja.d.18.00232

Cited by 13 publications

(15 citation statements)

References 12 publications

(20 reference statements)

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“…One case report published in 2020 was submitted to a journal in 2019. Table 2 presents a summary of the reports on sugammadex-induced anaphylaxis [ 14 , 15 , 16 , 17 , 18 ]. None of the five patients had previously been exposed to sugammadex.…”

Section: Resultsmentioning

confidence: 99%

“…The first case report of anaphylaxis caused by the sugammadex-rocuronium complex was reported in 2016 [ 28 ]. Several cases of anaphylaxis caused by the sugammadex-rocuronium complex have since been reported (one of them is included in Table 1 ) [ 14 , 29 , 30 ]. Structural changes caused by the combination of sugammadex and rocuronium can act independently as allergens that can cause anaphylaxis [ 30 ].…”

Section: Discussionmentioning

confidence: 99%

“…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 ]. Considering the trend of its rapidly increasing use for anesthesia, it is meaningful to investigate the incidence of sugammadex-induced anaphylaxis in a large-scale population.…”

Section: Introductionmentioning

confidence: 99%

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

Kim

Yang

et al. 2021

JCM

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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.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Kim

Yang

et al. 2021

JCM

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“…In contrast, hydrophobic molecules formed by gamma-cyclodextrin may penetrate body tissues may cause the release of active molecules. Anaphylaxis reactions with sugammadex-rocuronium complex [ 4 , 21 , 22 ] as well as anaphylaxis reactions with rocuronium [ 23 ] are available in the literature, which leads to confusion as to which is the real trigger in anaphylaxis. In the literature, the anaphylaxis reaction associated with sugammadex is not IgE/IgG-mediated [ 24 ].…”

Section: Discussionmentioning

confidence: 99%

Retrospective evaluation of the effects of Sugammadex and Neostigmine on the IgE and Eosinophil Cationic Protein in Morbid Obese Patients

Görgülü

Koşar

2020

North Clin Istanbul

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OBJECTIVE: This study was designed to show that allergic reactions with gamma cyclodextrin-related caused by sugammadex are not anaphylaxis but an anaphylactoid reaction. METHODS: In this retrospective study, 83 morbidly obese patients, who underwent elective laparoscopic sleeve gastrectomy operation, were included. Patient data were obtained from patient files and electronic health records system (SARUS). The patients were divided into two groups as sugammadex (Group S) and neostigmine (Group N). Patient data were recorded, including patient preoperative demographics (age, gender) and preoperative and postoperative (12 hours later) levels of total IgE and ECP (Eosinophil cationic protein) levels. RESULTS: There was not a significant change in the total IgE levels in Group S or Group N (p>0.05); however, the levels of ECP significantly decreased in both groups (p<0.001, p=0.01). In the patients in Group S, the preoperative levels of total IgE were significantly positively, and weakly correlated with the preoperative ECP (p=0.311, p=0.045) and postoperative ECP (p=0.310, p=0.046) levels. CONCLUSION: Allergic reactions that arise from sugammadex related with gamma-cyclodextrin are non-IgE mediated anaphylactoid reactions. Anaphylactoid reaction was not observed after administration of 2 mg kg - 1 sugammadex intravenously in patients with morbid obesity.

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“…There were 14 case reports and 5 case series of sugammadex-induced anaphylaxis, which allowed for data extraction of 28 individual patient cases [ Table 2 ]. [ 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 ] Because 3 patient cases did not meet the World Allergy Organization criteria for anaphylaxis,[ 21 32 33 39 ] only results from 25 patient cases were included in the final data tables. The age of patients ranged from 3 to 89 years old and was split between 13 males and 12 females.…”

Section: Case Reportsmentioning

confidence: 99%

Sugammadex-induced anaphylactic reaction: A systematic review

Zecic

Smart

Abbey

et al. 2022

J Anaesthesiol Clin Pharmacol

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Perioperative anaphylaxis is a rare, but life-threatening hypersensitivity reaction for patients undergoing surgical procedures. Sugammadex is a relatively new drug used to reverse the neuromuscular blockade of specific anesthetics in surgery. Several case reports indicate that there may be a risk of anaphylaxis associated with the use of sugammadex This review examines the literature in order to evaluate the strength of the association between sugammadex use and anaphylaxis. A query of PubMed, EMBASE, and Web of Science was conducted using a combination of terms to identify relevant articles from inception until March 9, 2020. We included any primary study that identified sugammadex as a probable causative agent based on the World Allergy Organization diagnostic criteria for anaphylaxis. A total of 24 articles were reviewed. Across the three randomized controlled trials, there were only four cases of anaphylaxis identified. Incidence of anaphylaxis was reported in only one trial at 0.33%. Two retrospective observational studies conducted in Japan identified cases of anaphylaxis, with incidences of 0.02 and 0.04%. Among 19 case reports and series, 25 patient cases of anaphylaxis were confirmed via allergy testing to be caused by sugammadex or sugammadex–rocuronium complex. Commonly reported symptoms included hypotension, erythema, and decreased oxygen saturation. Based on the findings of this review, there appears to be a rare, but serious, association of sugammadex-induced perioperative anaphylaxis with an incidence between 0.02 and 0.04% in observational studies. It is unclear whether sugammadex on its own or in complex with rocuronium triggers this reaction, but it is clearly involved in inducing anaphylaxis. Further population studies are needed to get a more accurate global incidence rate, and more detailed allergy testing is required to better describe which step of the sugammadex reversal pathway initiates the anaphylactic attack.

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Anaphylactic shock after sugammadex administration, induced by formation of a sugammadex-rocuronium complex -a case report-

Cited by 13 publications

References 12 publications

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

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

Retrospective evaluation of the effects of Sugammadex and Neostigmine on the IgE and Eosinophil Cationic Protein in Morbid Obese Patients

Sugammadex-induced anaphylactic reaction: A systematic review

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