Pharmacoepidemiological study of oxaliplatin safety (analysis of Russian spontaneous reporting database)

Objective. To assess oxaliplatin safety considering spontaneous adverse reaction (AR) reports and oxaliplatin consumption. Material and methods. Spontaneous AR reports with high cause-and-effect relations were obtained from the «Pharmacovigilance» subsystem of Roszdravnadzor’s automated information system (2015—2023). We excluded duplicate and non-valid reports. We assessed ARs after oxaliplatin therapy according to registered indications and off-label treatment, as well as original and generic oxaliplatin. Results. Analysis included 715 spontaneous AR reports where oxaliplatin was used for registered indications (colorectal cancer — 53.4%, ovarian cancer — 1.4%) and in off-label fashion (26%). The overall AR spectrum corresponded to known safety profile without new safety data. In oxaliplatin therapy for registered indications, the highest proportions of ARs were observed for immune (21%), respiratory (18.4%), nervous (10.4%) and vascular systems (12.3%), as well as skin (10.9%), gastrointestinal tract (9.2%), and blood (7.1%). Differences in AR frequency among system classes were attributed to the nature of spontaneous AR reporting. Off-label therapy demonstrated lower incidence of adverse reactions in immune and respiratory systems, as well as higher incidence of reactions in blood and gastrointestinal tract compared to registered indications. Adverse reactions following original oxaliplatin were comparable to that for generic drugs. Conclusion. Extensive research of oxaliplatin safety profile has been previously conducted. There were no new safety data. ARs varied depending on indications (registered or off-label) but were independent of whether it was original or generic products. © 2025 Elsevier B.V., All rights reserved.