Pharmacovigilance study of ramucirumab: A safety analysis based on the FDA adverse event reporting system.

BACKGROUND

This study analyzes adverse event (AE) signals associated with ramucirumab using data from the FDA Adverse Event Reporting System (FAERS) to provide evidence supporting the safety of the drug for clinical use.

METHODS

Data were extracted from the FAERS database using Open Vigil 2.1. Signal detection was performed using the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN) methods. AEs were categorized and described using the Preferred Terms (PTs) and System Organ Class (SOC) classifications from the Medical Dictionary for Regulatory Activities.

RESULTS

A total of 1,701 AE reports related to ramucirumab were retrieved. Most reported cases involved male patients (59.79%), most aged 65-74 years (25.57%), with Asia being the primary region of report origin (59.08%). Based on the screening criteria, 130 PT signals across 18 SOC categories were identified, of which 72 PTs were not listed in the drug label. Frequently reported and strongly signaled AEs included hypertension, ascites, proteinuria, edema, and neutropenia-events already noted in the prescribing information of the drug. However, additional AEs, such as pyogenic granuloma, brainstem hemorrhage, interstitial lung disease, and peritonitis, which were not included in the labeling, also showed strong signals and warrant further exploration.

CONCLUSIONS

The commonly reported AEs of ramucirumab observed in real-world data are consistent with those listed on the drug label. Nevertheless, new suspicious AEs were identified. Enhanced clinical vigilance, through pretreatment risk assessment and ongoing posttreatment monitoring, is recommended to ensure patient safety.