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Remdesivir in the COVID-19 Pandemic: An Analysis of Spontaneous Reports in VigiBase During 2020

Author

Listed:
  • Elena Rocca

    (Uppsala Monitoring Centre
    Norwegian University of Life Sciences)

  • Oskar Gauffin

    (Uppsala Monitoring Centre)

  • Ruth Savage

    (Uppsala Monitoring Centre
    University of Otago
    University of Otago)

  • Sara Hedfors Vidlin

    (Uppsala Monitoring Centre)

  • Birgitta Grundmark

    (Uppsala Monitoring Centre)

Abstract

Introduction The safety profile of remdesivir, conditionally approved for COVID-19, was limited at its 2020 introduction. Adverse drug reactions (ADRs) for medicines are collected in VigiBase, the WHO Global Database of Individual Case Safety Reports (ICSRs). Objective This study aimed to provide a descriptive analysis of COVID-19 ICSR data focusing on remdesivir, including a disproportionality analysis (DA) of ADRs. Methods A dedicated algorithm enabled retrieval of all COVID-19 treatment-specific ICSRs. A severity algorithm based on co-reported medicines and symptoms enabled selection of tocilizumab with its well established safety profile as comparator for remdesivir. Descriptive statistics were used for general ICSR demographics for all COVID-19-specific medicines, remdesivir and tocilizumab individually and furthermore to present treatment patterns of medicines co-reported with remdesivir. A COVID-19 indication-focused DA was deployed to minimize confounding from underlying polysymptomatic disease. Results 14,574 COVID-19-related ICSRs were entered into VigiBase during 2020. Remdesivir was the most common medicine reported. Of 4944 remdesivir ICSRs, where tocilizumab was not co-reported, 93% described remdesivir as the sole suspect medicine. Sixty percent of ICSRs concerned males, median age was 63 years and the majority originated from the Americas (72%). In 1089 (21%) of remdesivir ICSRs, data indicated severe/critical disease. Co-reported medicines peaked during the first 3 days of remdesivir treatment. The DA for the established tocilizumab and the new remdesivir were mainly in line with the safety profiles for both medicines but suggested new safety concerns. The most reported ADRs for remdesivir represented liver dysfunction, kidney injury, death and bradycardia. Conclusion Global COVID-19-related ADR reporting proved useful in providing information on ADRs as well as on treatment patterns in this patient group. Indication-focused disproportionality analysis, together with the use of a comparator with a known safety profile, proved effective in identifying known safety information and suggested new safety concerns for remdesivir.

Suggested Citation

  • Elena Rocca & Oskar Gauffin & Ruth Savage & Sara Hedfors Vidlin & Birgitta Grundmark, 2021. "Remdesivir in the COVID-19 Pandemic: An Analysis of Spontaneous Reports in VigiBase During 2020," Drug Safety, Springer, vol. 44(9), pages 987-998, September.
    • Handle: RePEc:spr:drugsa:v:44:y:2021:i:9:d:10.1007_s40264-021-01091-x
    DOI: 10.1007/s40264-021-01091-x
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    References listed on IDEAS

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    1. Alem Zekarias & Sarah Watson & Sara Hedfors Vidlin & Birgitta Grundmark, 2020. "Sex Differences in Reported Adverse Drug Reactions to COVID-19 Drugs in a Global Database of Individual Case Safety Reports," Drug Safety, Springer, vol. 43(12), pages 1309-1314, December.
    2. Devon E McMahon & Gregory A Peters & Louise C Ivers & Esther E Freeman, 2020. "Global resource shortages during COVID-19: Bad news for low-income countries," PLOS Neglected Tropical Diseases, Public Library of Science, vol. 14(7), pages 1-3, July.
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