| アブストラクト | BACKGROUND: We study the adverse events (AEs) of bamlanivimab (BAM), bamlanivimab/etesevimab (BAM/ETE) to alert risk factors during coronavirus disease 2019 (COVID-19) treatment and provide references for drug safety. RESEARCH DESIGN AND METHODS: Extract AEs from the COVID-19 Emergency Use Authorization (EUA) FDA Adverse Event Reporting System (FAERS) Public Dashboard. Disproportionality analysis was performed to discover the potential risks of BAM and BAM/ETE. RESULTS: With COVID-19 drugs as the research background, the number of BAM/ETE signals is about half that of BAM, and 80% of signals overlap with BAM. Signals such as atrial fibrillation, tachycardia, and confusional state are present in BAM but not in BAM/ETE. With BAM and BAM/ETE as the research background, potential safety signals of BAM/ETE such as acute respiratory failure, hypersensitivity, and infusion-related reaction require long-term observation, especially acute respiratory failure which is not in the label. CONCLUSIONS: The AEs report on this study confirm most of the label information of BAM and BAM/ETE. BAM/ETE is relatively safe, while the risk signals such as acute respiratory failure and infusion-related reaction require to be monitored. |
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| ジャーナル名 | Expert opinion on drug safety |
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| 投稿日 | 2022/10/1 |
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| 投稿者 | Zhao, Yunfei; Wang, Huiling; Zhang, Qingsong; Hu, Yongxin; Xu, Yulong; Liu, Wei |
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| 組織名 | School of Pharmaceutical Sciences, Zhengzhou University, Zhengzhou, Henan, China.;School of Pharmaceutical Sciences, Zhengzhou Railway Vocational and Technical;College, Zhengzhou, Henan, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/36178050/ |
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