Adverse events associated with SARS-CoV-2 neutralizing monoclonal antibodies using the FDA adverse event reporting system database

Min Joung Choi; Se-Hun Oh; Yun-Kyoung Song; Sung Hwan Ki

doi:10.1007/s43188-024-00256-x

Adverse events associated with SARS-CoV-2 neutralizing monoclonal antibodies using the FDA adverse event reporting system database

Toxicol Res. 2024 Jul 30;40(4):673-682. doi: 10.1007/s43188-024-00256-x. eCollection 2024 Oct.

Authors

Min Joung Choi¹, Se-Hun Oh², Yun-Kyoung Song², Sung Hwan Ki¹

Affiliations

¹ Research Institute of Pharmaceutical Sciences, College of Pharmacy, Chosun University, 309 Pilmun-Daero, Dong-gu, Gwangju, 61452 Republic of Korea.
² College of Pharmacy, The Catholic University of Korea, 43 Jibong-ro, Bucheon-Si, Gyeonggi-do 14662 Republic of Korea.

PMID: 39345748
PMCID: PMC11436521 (available on 2025-10-01)
DOI: 10.1007/s43188-024-00256-x

Abstract

The purpose of this study was to analyze the important medical events (IMEs) of anti-severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) monoclonal antibodies using the reports from the United States Food and Drug Administration (US FDA) adverse event reporting system (FAERS) and to detect safety signals. In this study, data from the FAERS from January 2020 to December 2022 were used to investigate signals associated with five monoclonal antibody products (bamlanivimab, bamlanivimab/etesevimab, bebtelovimab, casirivimab/imdevimab, sotrovimab) in coronavirus disease 2019 (COVID-19) patients and one monoclonal antibody product (tixagevimab/cilgavimab) in patients wherein COVID-19 vaccination was not recommended. Disproportionality analyses were conducted using the reporting odds ratio, and an information component to identify safety signals. There were 17,937,860 drug AE reports associated with all drugs in the FAERS documented during research period. Among them, 42,642 were AE reports associated with anti-SARS-CoV-2 monoclonal antibodies. The SOCs including respiratory, thoracic and mediastinal, and vascular disorders were frequently reported for all the six products. The three most commonly detected IMEs were hypoxia, COVID-19 pneumonia, and anaphylactic reaction due to SARS-CoV-2 neutralizing antibodies. Even though the purposes of use were different, the types of signals between drugs were similar. Careful monitoring of these AEs should be considered for certain COVID-19 patients, at risk, when they are treated with monoclonal antibody products.

Keywords: Adverse events; COVID-19; Emergency use authorization; FDA adverse event reporting system; SARS-CoV-2 neutralizing monoclonal antibody drugs.

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