ISSN: 1859 - 2872
Adverse reactions related to monoclonal antibodies: An analysis of the Vietnamese spontaneous ADR reporting system
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Abstract
Objective: To investigate the characteristics of adverse drug reactions related to monoclonal antibodies in the Vietnamese Database of spontaneous ADR reports. Subject and method: A cross-sectional retrospective study of spontaneous ADR reports registered at the National DI & ADR Center from 2017 to 2023. Result: Out of 378 ADR reports related to monoclonal antibodies, bevacizumab and rituximab were the most reported drugs with rates of 42.3% and 25.4%, respectively. Adverse reactions were diverse, with the most common including skin and subcutaneous tissue disorders (26.7%), blood and lymphatic system disorders (22.8%), and nervous system disorders (20.4%). The signals of anaphylaxis associated to monoclonal antibodies and some other medically significant ADRs associated with bevacizumab and rituximab have been detected. Conclusion: Amid the growing use of monoclonal antibodies, this study provides a partial overview of the safety profiles of monoclonal antibodies reported in Vietnam, thereby enhancing monitoring and mitigating the risks associated with these drugs in clinical practice.
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References
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