Signal mining and risk analysis of the over-indications use of bevacizumab

Abstract Objective To dig deeper into the Adverse events(ADEs) signal generated by bevacizumab in the past decade, and to compare and summarize the clinical characteristics and medication risks of the over-indications use of bevacizumab. Methods “Bevacizumab”, “ALYMSYS”, “AVASTIN”, “MVASI”, “VEGZELMA”, and “ZIRABEV” were used as search terms to extract relevant data from the FDA Adverse Event Reporting System(FAERS) from Q1 2014 to Q4 2023. We compared bevacizumab's specification with the “indi-pt” information in the database, to screen out the cases of over-indications and approved indications. Results The composition ratio of ADE cases generated by over-indications use (16.31%, 3.13%) was higher than that of approved indications use(3.32%, 0.24%) in general disorders and administration site conditions, and skin and subcutaneous tissue disorders. The median time to occurrence of ADEs for over-indications use was 57.5(199.00)d, and the main serious medical events were death(36.57%) and hospitalization-initial or prolonged(14.86%). Conclusion There are many cases of over-indications use of bevacizumab, and the severity of its ADEs needs to be taken more seriously. In addition to common ADEs, special attention needed to be paid to the occurrence of ADEs associated with general disorders and administration site conditions, as well as skin and subcutaneous tissue disorders.