Abstract
Vyxeos, a liposomal combination of cytarabine and daunorubicin, has improved survival outcomes for patients with high-risk acute myeloid leukemia (AML). However, its safety profile in real-world settings requires comprehensive evaluation. This study aims to assess the adverse event profiles associated with Vyxeos using data from the U.S. FDA's Adverse Event Reporting System (FAERS). A retrospective analysis of adverse event reports from the FAERS database was conducted for Vyxeos from January 2017 to June 2024. Reports were analyzed to assess patient demographics, system organ classes (SOCs), and preferred terms (PTs). Signal detection analysis was performed using disproportionality metrics, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS). A total of 1,036 reports were analyzed. The most frequently reported adverse events were hematologic (37.73%), infectious (28.42%), and cardiac disorders (13.22%). Febrile neutropenia, neutropenic sepsis, and pneumonia fungal were the most commonly reported events, with febrile neutropenia showing a strong association (ROR = 92.18). Males had a higher frequency of infectious events, while females reported more cardiac events. Most adverse events occurred within 30 days of treatment initiation, and 16.92% of reports involved hospitalization, while 18.33% reported death. Vyxeos is associated with significant hematologic, infectious, and cardiac adverse events. Close monitoring, infection prophylaxis, and cardiac assessments are recommended for patients receiving Vyxeos. Further research is needed to validate these findings and explore the mechanisms underlying the observed toxicities.