Hematological toxicities in bevacizumab associated with ovarian cancer: A pharmacovigilance study using FDA adverse event reporting system database.

Bevacizumab has demonstrated efficacy in the treatment of ovarian cancer. However, it can also induce severe toxicity in multiple organ systems, particularly the hematological system. Therefore, this study evaluated hematological toxicities associated with bevacizumab in ovarian cancer, using real-world data. Data were extracted from the FDA adverse event reporting system database, covering the period from Q1 2004 to Q4 2024. Further analyses were conducted on hematological toxicities related to bevacizumab, including their features, time-to-onset, and fatality proportions. Of the 5211 adverse event reports identified, 880 hematotoxicity reports (16.89%) were analyzed. Bevacizumab exhibited positive safety signals for hematological toxicity, as indicated by the reporting odds ratios and the information component analyses. Several adverse events not listed on the bevacizumab drug label were identified, including bone marrow failure, disseminated intravascular coagulation, thrombotic thrombocytopenic purpura, and atypical hemolytic uremic syndrome. The median time-to-onset of these toxicities was 30 days (interquartile range 10-104), and the fatality rate associated with hematological toxicities related to bevacizumab was 16%. This study indicates that hematological toxicities caused by bevacizumab may emerge early and can have catastrophic consequences. Therefore, early detection and appropriate management of these hematological toxicities associated with bevacizumab are essential.