Post-marketing safety surveillance of Abemaciclib: an observational, pharmacovigilance study leveraging FAERS database

Abemaciclib, a novel cyclin-dependent kinase 4 and 6 inhibitor, shows promising outcomes and far-reaching influence in the therapeutic scenario of women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer. Query the FAERS database retrospectively to extract reports related to Abemaciclib from the first quarter of 2004 to the first quarter of 2024. Reporting the odds ratio and Bayesian confidence propagation neural networks as well as the information component of the multi-item γ Poisson contractile apparatus was used to quantify the adverse event signal of the Abemaciclib.10,070 reports of Abemaciclib were identified and significantly associated with an increased risk of blood lymphatic system disorder and hepatobiliary disorders at the SOC level. New and Unexpected AEs include Embolism venous, Lymphangiosis carcinomatosa, Malignant neoplasm progression, Blood creatinine increased and Thrombosis were also be detected. The median time to onset of Abemaciclib-related AEs was 33 days, with the majority occurring within the initial month of Abemaciclib treatment. Gender and age differences existed in in the top 30 signal strength of PTs related to Abemaciclib. Our study found significant new AEs signals of Abemaciclib and reveal that different patient characteristics (such as age, gender, severity) affect treatment outcomes, which might provide support for clinical monitoring and risk identification of Abemaciclib.Our study validates the common AEs and some potential emerging safety concerns related to Abemaciclib in real clinical practice, which could potentially prompt increase the awareness of toxicities for Abemaciclib.