Incidence of hypersensitivity and anaphylaxis with sugammadex

• Published in: Journal of clinical anesthesia Vol. 47; pp. 67 - 73
• Main Authors: Min, K. Chris, Woo, Tiffany, Assaid, Christopher, McCrea, Jacqueline, Gurner, Deborah M., Sisk, Christine McCrary, Adkinson, Franklin, Herring, W. Joseph
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.06.2018; Elsevier Limited
• Subjects: Adult; Aged; Algorithms; Anaphylaxis; Anaphylaxis - chemically induced; Anaphylaxis - epidemiology; Anesthesia; Anesthesia Recovery Period; Anesthesia, General - adverse effects; Anesthesia, General - methods; Cholinesterase Inhibitors - adverse effects; Clinical trials; Drug Hypersensitivity - epidemiology; Drug Hypersensitivity - etiology; Female; Humans; Hypersensitivity; Incidence; Male; Middle Aged; Neostigmine - adverse effects; Neuromuscular Blockade - adverse effects; Neuromuscular Blockade - methods; Neuromuscular Nondepolarizing Agents - administration & dosage; Neuromuscular Nondepolarizing Agents - antagonists & inhibitors; Placebos - adverse effects; Product Surveillance, Postmarketing - statistics & numerical data; Randomized Controlled Trials as Topic; Retrospective Studies; Rocuronium - administration & dosage; Rocuronium - antagonists & inhibitors; Studies; Sugammadex; Sugammadex - adverse effects; Ireland; Hypersensitivity; Anaphylaxis; Sugammadex
• ISSN: 0952-8180; 1873-4529; 1873-4529
• DOI: 10.1016/j.jclinane.2018.03.018

To evaluate the incidence of hypersensitivity and anaphylaxis after administration of sugammadex. Retrospective analysis. Sugammadex clinical development program and post-marketing experience. Surgical patients and healthy volunteers who received sugammadex or placebo/comparator with anesthesia and/or neuromuscular blockade (NMB). Sugammadex administered as 2.0 mg/kg at reappearance of the second twitch, 4.0 mg/kg at 1–2 post-tetanic count, or 16.0 mg/kg at 3 min after rocuronium 1.2 mg/kg. Three analytical methods were used: 1) automated MedDRA queries; 2) searches of adverse events (AEs) consistent with treatment-related hypersensitivity reactions as diagnosed by the investigator; and 3) a retrospective adjudication of AEs suggestive of hypersensitivity by a blinded, independent adjudication committee (AC). In addition, a search of all post-marketing reports of events of hypersensitivity was performed, and events were retrospectively adjudicated by an independent AC. Anaphylaxis was determined according to Sampson Criterion 1. The pooled dataset included 3519 unique subjects who received sugammadex and 544 who received placebo. The automated MedDRA query method showed no apparent increase in hypersensitivity or anaphylaxis with sugammadex as compared to placebo or neostigmine. Similarly, there was a low overall incidence of AEs of treatment-related hypersensitivity (<1%), with no differences between sugammadex and placebo or neostigmine. Finally, the retrospective adjudication of AEs suggestive of hypersensitivity showed a low incidence of hypersensitivity (0.56% and 0.21% for sugammadex 2 mg/kg and 4 mg/kg, respectively), with an incidence similar to subjects who received placebo (0.55%). There were no confirmed cases of anaphylaxis in the pooled studies. During post-marketing use, spontaneous reports of anaphylaxis occurred with approximately 0.01% of sugammadex doses. Subjects who received sugammadex with general anesthesia and/or NMB had a low overall incidence of hypersensitivity, with no apparent increase in hypersensitivity or anaphylaxis with sugammadex as compared to placebo or neostigmine. •Sugammadex is indicated for reversal of moderate and deep neuromuscular blockade.•The incidence of hypersensitivity with sugammadex was assessed.•No increase in hypersensitivity was observed with sugammadex vs. placebo/neostigmine.•There were no confirmed cases of anaphylaxis in the pooled studies.•Reports of anaphylaxis during post-marketing use of sugammadex were rare.