In this episode, I’ll discuss the incidence of anaphylaxis to sugammadex.
Concerns over the rate of anaphylaxis to sugammadex delayed the US approval of the drug, with the FDA issuing a not approvable letter in 2008 citing in part concerns about allergic reactions.
When sugammadex was approved in 2015 the prescribing information provided the following warning for anaphylaxis:
Be prepared for hypersensitivity reactions (including anaphylactic reactions) and take necessary precautions
The prescribing information states the frequency of anaphylaxis to sugammadex was 0.3% in healthy volunteers, based on a study of 299 volunteers where one of which developed anaphylaxis.
A 1 in 300 incidence of anaphylaxis would mean centers that have adopted sugammadex as the routine reversal agent in the OR would experience significant numbers of anaphylactic cases annually, something that has not been reported.
Two large cohort studies have been published that find the incidence of anaphylaxis to sugammadex to be significantly less than 1 in 300.
The first large cohort study was published in 2018 and looked at over 15,000 patients in a single center. Six of these patients developed anaphylaxis for an incidence of approximately 1 in 2500.
The second large cohort study was published in 2021 and included almost 20,000 patients from a single center. Two of these patients developed anaphylaxis for an incidence of approximately 1 in 10,000.
These incidence rates are similar to those found with succinylcholine and rocuronium.
These cohort studies suggest that while sugammadex does have a risk of anaphylaxis, it occurs at least an order of magnitude less than described in the prescribing information.
To access my free download area with 20 different resources to help you in your practice, go to pharmacyjoe.com/free.
If you like this post, check out my book – A Pharmacist’s Guide to Inpatient Medical Emergencies: How to respond to code blue, rapid response calls, and other medical emergencies.