A real-world analysis of FDA Adverse Event Reporting System (FAERS) events for liposomal nanoparticle-formulated and...

Despite the established use of both liposomal irinotecan and conventional irinotecan, a comparative analysis of their safety profiles is lacking. This study leverages the FDA Adverse Event Reporting System (FAERS) database to fill this gap by comparing their adverse events (AEs) to inform clinical practice.

AEs were categorized by System Organ Class (SOC) and described using Preferred Terms (PTs) from the Medical Dictionary for Regulatory Activities (MedDRA, v26.1). The signals for liposomal irinotecan and irinotecan were quantified through disproportionality analysis, employing multiple algorithms: the reporting odds ratio (ROR), proportional reporting ratio (PRR), multi-item gamma poisson shrinker (MGPS), and Bayesian confidence propagation neural network (BCPNN).

A total of 934 and 10,362 AE reports were retrieved for liposomal irinotecan and irinotecan, respectively, with each drug involving 25 and 27 System Organ Class (SOC) categories. At the SOC level, both drugs have significant SOC-level signals value for "Gastrointestinal Disorders", "Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)", "Blood And Lymphatic System Disorders", "Metabolism And Nutrition Disorders", "Hepatobiliary Disorders", and "Congenital, Familial And Genetic Disorders". For liposomal irinotecan, 61 effective PT-level signals were detected, dominated by gastrointestinal disorders (diarrhoea). For irinotecan, 431 effective PT-level signals were detected, dominated by gastrointestinal disorders (diarrhoea) and blood and lymphatic system disorders (neutropenia). Comparative analysis revealed distinct safety profiles between the two drugs. Irinotecan demonstrated a stronger association with hematological and gastrointestinal events, including neutropenia, febrile neutropenia, and diarrhea, as well as with decreased appetite. For patients treated with liposomal irinotecan and irinotecan, the majority of AEs manifested within 30 days after the initiation of therapy.

As the first FAERS-based study comparing liposomal irinotecan and irinotecan, this analysis provides crucial evidence for clinical decision-making. While the detected signals indicate statistical associations, further clinical studies are warranted to establish causality and strengthen drug safety evaluation.