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Post-Marketing Safety Concerns with Nirmatrelvir: A Disproportionality Analysis of Spontaneous Reports Submitted to the FDA Adverse Event Reporting System
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  • Wei Zhuang,
  • Jiabing Xu,
  • Ye Wu,
  • Jianhui Yang,
  • Xiuxian Lin,
  • Yufang Liao,
  • Jun Wan,
  • Lizhu Weng,
  • Wanlong Lin
Wei Zhuang
Xiamen University School of Medicine
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Jiabing Xu
Fujian University of Traditional Chinese Medicine
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Ye Wu
The First Affiliated Hospital of Xiamen University
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Jianhui Yang
Xiamen University School of Medicine
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Xiuxian Lin
Xiamen University School of Medicine
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Yufang Liao
Xiamen University School of Medicine
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Jun Wan
Xiamen University School of Medicine
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Lizhu Weng
Xiamen University School of Medicine
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Wanlong Lin
Xiamen University School of Medicine

Corresponding Author:lwl21029@163.com

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Abstract

Aim: Nirmatrelvir as a new 3CL protease inhibitor for treating COVID-19 drug of antiviral drug, the potential side effects have not yet been fully studied yet. The aim of this study was to identify potential risk of Nirmatrelvir by analyzing post-marketing safety data based on the largest publicly available worldwide pharmacovigilance database. Methods: We analyzed Nirmatrelvir adverse events to detect and characterize relevant safety signals based on the FDA Adverse Event Reporting System database in 2022. Case/non-case approach were used to estimate the reporting odds ratio (ROR) and information component (IC) with relevant confidence intervals (95% CI) for AEs with ≥4 counts. Results: Total of 26846 cases were included. Disease recurrence [ROR(95%CI)=413.2(395.6-431.59)], dysgeusia [ROR(95%CI)=110.84(106.04-115.85)], anosmia [ROR(95%CI)=15.21(12.76-18.11)], ageusia [ROR(95%CI)=9.80(8.50-11.3)] and urticaria [ROR(95%CI)=1.91(1.69-2.17)] were the main safety signals. In addition, abdominal pain upper and skin toxicity were two specific safety signals of Nirmatrelvir. In pregnant population, a significant increased ROR was found in life-threatening [ROR(95%CI)=5.12(1.38-19.00)]. Conclusion: We identified that disease recurrence, dysgeusia, abdominal pain upper and skin toxicity were the main and specific safety signals of Nirmatrelvir. Clinician and pharmacist should pay attention on these AEs. Notably, a potential risk of Nirmatrelvir in pregnant population should be alerted.
10 Feb 2023Submitted to British Journal of Clinical Pharmacology
10 Feb 2023Submission Checks Completed
10 Feb 2023Assigned to Editor
10 Feb 2023Review(s) Completed, Editorial Evaluation Pending
14 Feb 2023Reviewer(s) Assigned
25 Mar 2023Editorial Decision: Revise Major
06 Apr 20231st Revision Received
06 Apr 2023Submission Checks Completed
06 Apr 2023Assigned to Editor
06 Apr 2023Review(s) Completed, Editorial Evaluation Pending
10 Apr 2023Editorial Decision: Revise Minor
15 Apr 20232nd Revision Received
16 Apr 2023Submission Checks Completed
16 Apr 2023Assigned to Editor
16 Apr 2023Review(s) Completed, Editorial Evaluation Pending
04 May 2023Editorial Decision: Accept