A pharmacovigilance study of FDA adverse events for sugammadex
Authors' conclusion
The study identified unexpected and potentially life-threatening AEs associated with sugammadex, a valuable agent for rapidly reversing neuromuscular blockade.
Study context
- Population
- Adverse events (AEs) related to sugammadex reported in FDA Adverse Event Reporting System (FAERS), January 2009 to September 2023
- Participants
- 1,452 reports
- Outcome
- Sugammadex-related AEs (significant disproportionality signals at preferred term level)
Methodological detailsdisproportionality analysis of FAERS reports, reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN) and MGPS
- Disproportionality analysis of FAERS reports
- ROR, PRR, BCPNN and MGPS
Main finding
As reported in the abstract
Sugammadex-related AEs at preferred term level
Sugammadex-related AEs identified, including anaphylactic reaction, bradycardia, bronchospasm and cardiac arrest
98
Unexpected AEs absent from FDA labeling
37
AEs recognised as IME warranting observation
50
Serious AEs absent from labeling needing IME surveillance, including Kounis syndrome, angioedema, pulseless electrical activity and laryngeal edema
19
Original publication
A pharmacovigilance study of FDA adverse events for sugammadex. J Clin Anesth. Published 15 June 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →