A pharmacovigilance study of adverse event profiles and haemorrhagic safety of bevacizumab based on the FAERS database

ABSTRACTBackground Bevacizumab is used for the treatment of advanced malignant tumors; it acts by inhibiting angiogenesis. This study aimed to examine adverse events (AEs) of bevacizumab, especially hemorrhage, using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.Research Design and Methods The reporting odds ratio (ROR) and proportional reporting ratio (PRR) were used to analyze the AEs of bevacizumab using FAERS registration data from January 2004 to September 2022. Clinical information regarding hemorrhagic signals was further analyzed.Results The number of bevacizumab-associated AE reports was 96,477. Our study found that 892 significant preferred terms (PTs) were spread throughout 25 organ systems. The system organ classes (SOCs) focus on general disorders, administration site conditions, blood and lymphatic system disorders, injury, poisoning, and procedural complications. A total of 2,847 bevacizumab-related hemorrhage cases were reported, and 37 hemorrhagic signals were identified. Hemorrhagic signals were focused on SOC levels in vascular, gastrointestinal, and nervous system disorders. Colorectal, lung, and breast cancers are the three most common malignancies associated with BV-induced hemorrhage.Conclusion The AE report from the present study confirms the majority of label information for bevacizumab, while also identifying new AEs. In addition, this was a large descriptive study of bevacizumab-induced hemorrhage.KEYWORDS: Adverse eventbevacizumabdata miningFAERSpharmacovigilance Declaration of interestsThe authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.Supplementary materialSupplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2023.2248876Reviewer disclosuresPeer reviewers on this manuscript have no relevant financial or other relationships to disclose.Author contribution statementLinlin Tang: Methodology, Data curation, Formal analysis, Writing-original draft.Chuanhua Ding: Methodology, Data curation, Writing-review & editing. Hongying Li, Guoqiang Yin, Haixia Zhang: Methodology, Data curation.Wen Shan Liu: Conceptualization, Formal analysis, Supervision, Writing-review & editing.Yinghui Ji and Hui Li: Methodology, Data curation.All authors drafted the manuscript, participated in data analyses and interpretation, and revisions of the manuscript and approved the final version.Additional informationFundingThis paper was funded by the 2021 Shandong Medical Association Clinical Research Fund – Qilu Special Project -No. YXH2022ZX02055.