Cardiovascular Adverse Events Associated with Monoclonal Antibody Products in Patients with COVID-19
Little is known about cardiovascular safety profiles for monoclonal antibody products that received the FDA Emergency Use Authorization for COVID-19. In this study, data from the FDA Adverse Event Reporting System from the first quarter of 2020 to the second quarter of 2022 were used to investigate...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-11-01
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| Series: | Pharmaceuticals |
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| Online Access: | https://www.mdpi.com/1424-8247/15/12/1472 |
| _version_ | 1797455798953050112 |
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| author | Jingrui Zou Fuyuan Jing |
| author_facet | Jingrui Zou Fuyuan Jing |
| author_sort | Jingrui Zou |
| collection | DOAJ |
| description | Little is known about cardiovascular safety profiles for monoclonal antibody products that received the FDA Emergency Use Authorization for COVID-19. In this study, data from the FDA Adverse Event Reporting System from the first quarter of 2020 to the second quarter of 2022 were used to investigate cardiovascular safety signals associated with seven monoclonal antibody products (casirivimab + imdevimab, bamlanivimab, bamlanivimab + etesevimab, sotrovimab, tocilizumab, bebtelovimab, tixagevimab + cilgavimab) in COVID-19 patients. Disproportionality analyses were conducted using reporting odds ratio and information component to identify safety signals. About 10% of adverse events in COVID-19 patients were cardiovascular adverse events. Four monoclonal antibody products (casirivimab + imdevimab, bamlanivimab, bamlanivimab + etesevimab, and bebtelovimab) were associated with higher reporting of hypertension. Tocilizumab was associated with higher reporting of cardiac failure and embolic and thrombotic event. Casirivimab + imdevimab and bamlanivimab were also associated with higher reporting of ischemic heart disease. No cardiovascular safety signals were identified for sotrovimab and tixagevimab + cilgavimab. The results indicate differential cardiovascular safety profiles in monoclonal antibodies. Careful monitoring of cardiovascular events may be considered for certain COVID-19 patients at risk when they are treated with monoclonal antibodies. |
| first_indexed | 2024-03-09T15:59:00Z |
| format | Article |
| id | doaj.art-149819f6a8c04e19893929f49f8c2bdc |
| institution | Directory Open Access Journal |
| issn | 1424-8247 |
| language | English |
| last_indexed | 2024-03-09T15:59:00Z |
| publishDate | 2022-11-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceuticals |
| spelling | doaj.art-149819f6a8c04e19893929f49f8c2bdc2023-11-24T17:15:44ZengMDPI AGPharmaceuticals1424-82472022-11-011512147210.3390/ph15121472Cardiovascular Adverse Events Associated with Monoclonal Antibody Products in Patients with COVID-19Jingrui Zou0Fuyuan Jing1Department of Scientific Affairs, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, ChinaIndependent Researcher, Marlboro, NJ 07746, USALittle is known about cardiovascular safety profiles for monoclonal antibody products that received the FDA Emergency Use Authorization for COVID-19. In this study, data from the FDA Adverse Event Reporting System from the first quarter of 2020 to the second quarter of 2022 were used to investigate cardiovascular safety signals associated with seven monoclonal antibody products (casirivimab + imdevimab, bamlanivimab, bamlanivimab + etesevimab, sotrovimab, tocilizumab, bebtelovimab, tixagevimab + cilgavimab) in COVID-19 patients. Disproportionality analyses were conducted using reporting odds ratio and information component to identify safety signals. About 10% of adverse events in COVID-19 patients were cardiovascular adverse events. Four monoclonal antibody products (casirivimab + imdevimab, bamlanivimab, bamlanivimab + etesevimab, and bebtelovimab) were associated with higher reporting of hypertension. Tocilizumab was associated with higher reporting of cardiac failure and embolic and thrombotic event. Casirivimab + imdevimab and bamlanivimab were also associated with higher reporting of ischemic heart disease. No cardiovascular safety signals were identified for sotrovimab and tixagevimab + cilgavimab. The results indicate differential cardiovascular safety profiles in monoclonal antibodies. Careful monitoring of cardiovascular events may be considered for certain COVID-19 patients at risk when they are treated with monoclonal antibodies.https://www.mdpi.com/1424-8247/15/12/1472monoclonal antibodiesFAERScardiovascular adverse eventspharmacovigilance analysis |
| spellingShingle | Jingrui Zou Fuyuan Jing Cardiovascular Adverse Events Associated with Monoclonal Antibody Products in Patients with COVID-19 Pharmaceuticals monoclonal antibodies FAERS cardiovascular adverse events pharmacovigilance analysis |
| title | Cardiovascular Adverse Events Associated with Monoclonal Antibody Products in Patients with COVID-19 |
| title_full | Cardiovascular Adverse Events Associated with Monoclonal Antibody Products in Patients with COVID-19 |
| title_fullStr | Cardiovascular Adverse Events Associated with Monoclonal Antibody Products in Patients with COVID-19 |
| title_full_unstemmed | Cardiovascular Adverse Events Associated with Monoclonal Antibody Products in Patients with COVID-19 |
| title_short | Cardiovascular Adverse Events Associated with Monoclonal Antibody Products in Patients with COVID-19 |
| title_sort | cardiovascular adverse events associated with monoclonal antibody products in patients with covid 19 |
| topic | monoclonal antibodies FAERS cardiovascular adverse events pharmacovigilance analysis |
| url | https://www.mdpi.com/1424-8247/15/12/1472 |
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