A real-world retrospective study of romidepsin: Insights from the Food and Drug Administration Adverse Event...

This study aimed to identify adverse event signals associated with romidepsin using data from the Food and Drug Administration Adverse Event Reporting System to provide evidence supporting drug safety in clinical practice. Adverse event reports were extracted from the Food and Drug Administration Adverse Event Reporting System covering the period from the 3rd quarter of 2009 to the 4th quarter of 2024. Risk signals were analyzed using 4 disproportionality algorithms: the Bayesian geometric mean, reporting odds ratio, Bayesian confidence propagation neural network, and proportional reporting ratio. A total of 1545 romidepsin-related adverse event reports were identified. Disproportionality analysis revealed 21 system organ classes and 125 preferred terms associated with romidepsin. Commonly reported adverse events included thrombocytopenia, anemia, QT interval prolongation, and neutropenia. Several additional events not listed on the drug label were also detected, such as cardiac tamponade, elevated troponin I, and mental status changes. These findings contribute to the ongoing evaluation of the safety profile of romidepsin and can inform clinical monitoring and risk assessment. The newly identified adverse events warrant further investigation to elucidate their underlying mechanisms.