Safety of sugammadex for reversal of neuromuscular block: a
post-marketing study based on the World Health Organization
pharmacovigilance database
Abstract
Aim: Residual neuromuscular blockade is a common complication after
general anaesthesia. Sugammadex can reverse the action of aminosteroid
neuromuscular blockers. Our study aimed to explore sugammadex safety
issues in the real world and determine the spectrum of adverse
reactions. Methods: All sugammadex-related adverse events reported in
VigiBase between 2010 and 2019 were classified by group queries
according to the Medical Dictionary for Regulatory Activities. A
disproportionality analysis of data was performed using the information
component (IC); positive IC values were deemed significant. Results:
Overall, 16,219,410 adverse events were reported, and 2032 were
associated with sugammadex. The most frequent reactions were recurrence
of neuromuscular blockade (n = 54, IC: 6.74, 95% credibility interval
[CI]: 6.33–7.10), laryngospasm (n = 53, IC: 6.05, IC025:5.64),
bronchospasm (n = 119, IC: 5.63 , IC025:5.36), and bradycardia (n = 169,
IC: 5.13, IC025:4.90). Fatal cases were more likely with cardiac
disorders, especially in patients over 65 years. In addition, the common
adverse drug reactions (ADRs) differed between different age groups (P
< 0.01). The ADRs were higher between 0–17 years than in
other age groups. The onset time of common ADRs was typically within one
day, and 68.9% occurred within half an hour after sugammadex
administration. Conclusions: Anaesthesiologists should carefully monitor
the anaesthesia recovery period to correct the adverse drug reactions
caused by sugammadex and recommend monitoring neuromuscular function
throughout the anaesthesia process. Sugammadex should be used carefully
in patients with cardiovascular diseases, and ECG and hemodynamic
changes monitored after medication.