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Created October 11, 2018, last updated almost 3 years ago.
Collection: 91, Score: 1696, Trend score: 0, Read count: 2058, Articles count: 17, Created: 2018-10-11 23:36:19 UTC. Updated: 2022-01-27 02:30:49 UTC.Notes
Sugammadex is pharmacologically great. A modified γ-cyclodextrin Selective Relaxant Binding Agent that reverses rocuronium muscle relaxation 10-times faster than neostigmine (see: Is sugammadex as good as we think?).
At launch, its biggest obvious disadvantage was simply the new drug's high cost. Now as sugammadex has become more widely used, sugammadex-anaphylaxis has risen as a new, prominent concern.
In Japan, where there was a uniquely rapid take-up of sugammadex, it became one of the commonest causes of anaphylaxis. Oriharia (2020) demonstrated an incidence of sugammadex anaphylaxis in Japan of 1 in 5,000 – a risk that most medically communities would consider too high for routine use of a drug with acceptable alternatives.
Given that in some regions (notably Australia & New Zeleand) rocuronium itself has a high-risk of anaphylaxis, the combination of rocuronium-sugammadex may present a greater risk than even old-school drugs such as suxamethonium.
In other countries, such as the United Kingdom, there has not been quite the same incidence of sugammadex-anaphylaxis. Is this simply because of the lower initial use than in Japan, or are there environmental and phenotypical differences as have been implicated for rocuronium anaphylaxis?
Worryingly, if the Japanese experience is representative, then for some locations the combination of rocuronium-sugammadex may in fact have a higher risk of anaphylaxis than using suxamethonium alone.
The true risk of sugammadex-anaphylaxis is still unclear for many populations. However with the looming expiry of the sugammadex patent in 2023, we will see a rapid increase in its use and subsequently reveal any latent anaphylaxis risk.
Daniel Jolley
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Collected Articles
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Multicenter Study Comparative Study Observational Study
Comparison of incidence of anaphylaxis between sugammadex and neostigmine: a retrospective multicentre observational study.
In Japan, Sugammadex anaphylaxis occurs in ~1 in 5,000 exposures.
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Randomized Controlled Trial Multicenter Study
Hypersensitivity incidence after sugammadex administration in healthy subjects: a randomised controlled trial.
We evaluated the incidence of hypersensitivity or anaphylaxis after repeated single-dose sugammadex administration in non-anaesthetised adults. ⋯ NCT02028065.
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Randomized Controlled Trial
Sugammadex hypersensitivity and underlying mechanisms: a randomised study of healthy non-anaesthetised volunteers.
We investigated potential for hypersensitivity reactions after repeated sugammadex administration and explored the mechanism of hypersensitivity. ⋯ http://www.clinicaltrials.gov NCT00988065; Protocol number P06042.
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Anaesth Intensive Care · Jan 2014
Case ReportsIntraoperative anaphylaxis to sugammadex and a protocol for intradermal skin testing.
Sugammadex is a selective binding agent for aminosteroid neuromuscular blockers whose use is increasing in anaesthetic practice. We present three cases of severe anaphylaxis coincident with sugammadex administration. ⋯ As all patients were administered sugammadex to reverse neuromuscular blockade with rocuronium, we considered that sugammadex-rocuronium complexes were a potential unique allergen. In the two patients who were additionally tested with a rocuronium-sugammadex (3.6:1 molecular ratio) mixture, the wheal-and-flare response was significantly attenuated.
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We describe a case of a patient undergoing open abdominal aneurysm surgery who developed a severe, life-threatening allergic reaction immediately after administration of sugammadex. The manifestation was purely a cardiovascular collapse. ⋯ Sugammadex was confirmed as the cause of the anaphylaxis by a positive intradermal allergy test (25 mm diameter response to 1:100 dilution), with a normal saline control and a negative response to the other drugs used during the event. This case report is a reminder that the use of sugammadex is associated with rare but serious risks.
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Sugammadex has a unique mechanism of action and is widely used because of its safety and efficacy. A few recent reports have described allergic reactions to clinical doses of sugammadex. We hereby describe another series of cases of possible anaphylaxis to sugammadex. ⋯ Our results suggest that physicians using sugammadex should be aware of the possibility of sugammadex-induced anaphylaxis.
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Sugammadex is a drug used to reverse neuromuscular blockade induced by rocuronium or vecuronium. It has not yet been approved by the Food and Drug Administration in the USA due to concerns regarding hypersensitivity. The objective of this review was to identify similarities in the presentation of hypersensitivity reactions to sugammadex. ⋯ All cases that reported exact timing (14/15) occurred in 4 min or less. Most of the patients (11/15; 73%) met World Anaphylaxis Organization criteria for anaphylaxis. Awareness must be raised for the possibility of drug-induced hypersensitivity during the critical 5-min period immediately following sugammadex administration.
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Case Reports
The First Case Report of Anaphylaxis Caused by the Inclusion Complex of Rocuronium and Sugammadex.
A 50-year-old man developed a severe anaphylactic reaction shortly after the administration of sugammadex at the end of an uneventful laparoscopic appendectomy. Subsequent skin testing was negative to all agents to which the patient was exposed including sugammadex. ⋯ This is the first case report of anergy to the individual components but sensitivity to the inclusion complex of rocuronium and sugammadex. Written informed consent was obtained from the patient for skin testing, photography, laser perfusion imaging, and publication of this case report.
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Journal of anesthesia · Feb 2017
Case ReportsA suspected case of rocuronium-sugammadex complex-induced anaphylactic shock after cesarean section.
An anaphylactic reaction during a cesarean section occurs rarely, and rocuronium is thought to be one of the common agents causing perioperative anaphylaxis. Here we report an anaphylactic shock after cesarean section that is suggested to be induced by the rocuronium-sugammadex complex. A 36-year-old primigravida underwent an elective cesarean section under general anesthesia due to placenta previa. ⋯ We finally concluded that the rocuronium-sugammadex complex is the causative agent in this case. To the best of our knowledge, this is the first report suggesting anaphylaxis caused by the rocuronium-sugammadex complex. This case highlights the importance of appropriate examinations to determinate the pathogenesis of anaphylaxis in order to establish risk reduction strategies.
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A reminder that hypersensitivity reactions are possible with almost any drug or chemical. At the time of this publication, the risk of anaphylaxis to sugammadex appeared to be lower than that for muscle relaxants – however newer studies from Merck (Kam 2018 and Min 2018) worryingly suggest that sugammadex sensitivity may be a lot more common than we thought.
The FDA’s caution now no longer seems quite so unwarranted...
summary -
We retrospectively investigated the incidence of potential sugammadex-induced anaphylaxis at a single center in Japan over a period of 3 years. The overall incidence of intraoperative hypersensitivity reaction was 0.22% (95% confidence interval [CI], 0.17%-0.29%), and the incidence of anaphylaxis was 0.059% (95% CI, 0.032%-0.10%). ⋯ This result implies that the incidence of sugammadex-associated anaphylaxis could be as high as that for succinylcholine or rocuronium. A prospective study, including testing for identification of cause, is necessary to confirm the exact incidence of sugammadex-induced anaphylaxis; however, the present finding calls attention to this potential.
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summary“Cyclodextrin is frequently used in foods and cosmetics because it can change the physical properties of various compounds by their encapsulation within the cyclic structure. The average person is thought to ingest about 4 g of gamma-cyclodextrin per day from food. ... even people who have never received sugammadex may be sensitised by food and cosmetics.” (Mertes 2019)
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Perioperative anaphylaxis is a life-threatening clinical condition that is typically the result of drugs or substances used for anesthesia or surgery. The most common cause of anaphylaxis during anesthesia is reportedly neuromuscular blocking agents. Of the many muscle relaxants that are clinically available, rocuronium is becoming popular in many countries. ⋯ Thus, anesthesiologists should be familiar with the epidemiology, mechanisms, and clinical presentations of anaphylaxis induced by these drugs. In this review, we focus on the diagnosis and treatment of anaphylaxis to sugammadex and neuromuscular blocking agents. Moreover, we discuss recent studies in this field, including the diagnostic utility of flow cytometry and improvement of rocuronium-induced anaphylaxis with the use of sugammadex.
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