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Safety of sugammadex for reversal of neuromuscular block: a post-marketing study based on the World Health Organization pharmacovigilance database
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  • Qiang Lyu,
  • Pei Ye,
  • Hewei Zhang,
  • Xiaofei Ye,
  • Yi Zheng,
  • Jinfang Xu,
  • Xiao Chen,
  • Chenxin Chen,
  • Xiaojing Guo
Qiang Lyu
Naval Medical University

Corresponding Author:[email protected]

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Pei Ye
Huadong Hospital Affiliated to Fudan University
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Hewei Zhang
Naval Medical University Faculty of Health Service
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Xiaofei Ye
Second Military Medical University Department of Health Statistics
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Yi Zheng
Second Military Medical University Department of Health Statistics
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Jinfang Xu
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Chenxin Chen
Second Military Medical University Department of Health Statistics
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Xiaojing Guo
Second Military Medical University Department of Health Statistics
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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.
14 Mar 2022Submitted to British Journal of Clinical Pharmacology
16 Mar 2022Submission Checks Completed
16 Mar 2022Assigned to Editor
20 Mar 2022Reviewer(s) Assigned
10 Apr 2022Review(s) Completed, Editorial Evaluation Pending
10 Apr 2022Editorial Decision: Revise Major
06 May 20221st Revision Received
06 May 2022Submission Checks Completed
06 May 2022Assigned to Editor
06 May 2022Review(s) Completed, Editorial Evaluation Pending
11 May 2022Editorial Decision: Accept
08 Jun 2022Published in British Journal of Clinical Pharmacology. 10.1111/bcp.15417