A real-world pharmacovigilance study of romidepsin based on FDA adverse event reporting system database

Romidepsin is a class I-selective histone deacetylase (HDAC) inhibitor indicated for the treatment of adult patients with cutaneous T-cell lymphoma (CTCL) who have received at least one prior systemic therapy and for adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Despite its clinical use, large-scale safety data remain limited. This study leverages the FDA Adverse Event Reporting System (FAERS) database to characterize romidepsin-associated adverse events (AEs) in real-world settings, aiming to enhance clinical risk management.

Data from the FAERS database, spanning from January 2014 to March 2025, served as the basis for this analysis. To evaluate the association between romidepsin and AEs, multiple disproportionality analyses were employed, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS).

Within the specified reporting period, 17,448,626 AE reports were recorded in the FAERS database, of which 1,285 events were associated with romidepsin. Based on four calculation methods, 101 preferred terms (PTs) related to romidepsin were determined. Common AEs included thrombocytopenia, pyrexia, anemia, electrocardiogram QT prolonged, and infections, aligning with the drug label. In addition, some unanticipated major AEs were detected, including cardiotoxicities beyond QT prolongation (acute cardiac failure, atrial fibrillation, sinus tachycardia, mitral valve incompetence, and bundle branch block left) alongside other significant AEs: hepatic failure, amenorrhea, mental status changes, glomerular filtration rate decreased, embolism, and retinal detachment.

This study provides a systematic evaluation of AEs associated with romidepsin, confirming its established safety profile and identifying several emerging safety concerns in a real-world setting. These findings offer valuable insights to assist clinicians and pharmacists in better-managing romidepsin's safety.