Objectives: Hemorrhage is a serious ADR of bevacizumab which may lead to life-threatening consequences.The aim of this study was to evaluate the risk of hemorrhage in reported patients treated with bevacizumab.
Methods: The study evaluated the cases with bevacizumab therapy reported in the National Adverse Drug Reactions (ADRs) Reporting System. After excluding the foreign and duplicated cases,remaining cases were reviewed and further analyzed by descriptive statistics. Results: Hemorrhage was the most commonly reported adverse reaction (n = 81) of the domestic reports (n = 467), especially gastrointestinal hemorrhage (n = 29) and perforation (n = 17) in the past 8 years. Other common bleeding sites were epistaxis (n = 12), pulmonary hemorrhage/hemoptysis (n = 6) and intracranial hemorrhage (n = 5). There were 15 death reports, but most cases resulted in hospitalization (n = 29) or non-serious adverse reaction (n = 25). Reports were mostly received from patients with colorectal cancer (n = 38), non-small-cell lung cancer (n = 9), and renal cell carcinoma (n = 9). Moreover, we did not observe a positive correlation between the dose of bevacizumab and the outcome of hemorrhage events. Conclusions: Hemorrhage is indeed a common risk of bevacizumab, which cannot be ignored. Thus patients should be monitored for signs and symptoms of bleeding in order to ensure safe use of medications.