A Real-World Pharmacovigilance Analysis for Demethylation Drug: Findings from the FDA Adverse Event Reporting Database

作者：Shupeng Chen, Jie Liu, Yao Gao, Nana Tang, Yingjian Zeng · 发表于：Oncology · 年份：2025 · DOI：10.1159/000543519 · 被引用次数：4 · 研究领域：Pharmacovigilance and Adverse Drug Reactions、Blood disorders and treatments、Drug-Induced Adverse Reactions

INTRODUCTION: The real-world safety profiles of the demethylating agents azacitidine and decitabine remain inadequately characterized despite their widespread clinical use. Both drugs are extensively employed for the treatment of hematologic malignancies such as myelodysplastic syndromes and acute myeloid leukemia. This study aimed to evaluate their adverse event profiles by leveraging data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. METHODS: All adverse drug event (ADE) data related to azacitidine and decitabine were collected from the FAERS database from its inception through the second quarter of 2024 (Q2). After standardizing the data, four disproportionality methods were applied to evaluate the association between azacitidine, decitabine, and ADEs. The Weibull shape parameter was used to analyze the time-to-onset curves. RESULTS: Among the 15,538 ADEs where azacitidine was the primary suspect drug, a total of 439 preferred terms (PTs) and 2 system organ classes (SOCs) showed significant disproportionality across all four algorithms. These SOCs included infections and infestations (n = 7,328, ROR 3.78) and blood and lymphatic system disorders (n = 5,613, ROR 8.92). Compared with the azacitidine label, 52 previously unreported ADEs were identified at the PT level. Among the 3,064 ADEs where decitabine was the primary suspect drug, a total of 200 PTs and two SOCs exhibited significant disproportionality across all four alg...