Unveiling unexpected adverse events and haemorrhagic safety: post-marketing safety surveillance of ramucirumab from the FAERS database.

Abstract

Background: This study aimed to investigate the overall and haemorrhagic safety profile of ramucirumab based on Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods: A retrospective disproportionality analysis using reporting odds ratio (ROR), proportional reporting ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN) was performed to evaluate adverse event reporting associated with ramucirumab.

Results: A total of 7901 AEs of ramucirumab and 233 risk signals involving 19 system organ classes (SOCs) were identified. The main AEs associated with ramucirumab including haemorrhage, gastrointestinal perforations, and proteinuria were consistent with the package insert. New potential unexpected AEs including interstitial lung disease, pyogenic granuloma, osteonecrosis of the jaw, and myelodysplastic syndrome should be paid more attention. Subgroup analysis of 490 cases of ramucirumab-associated haemorrhage revealed that positive signals were distributed across 8 SOCs with 32 positive signals, with unexpected signals found in nervous system, renal and urinary, and eye disorders. Additionally, more than half of AE cases occurred within the first month with a median onset time of 27 days.

Conclusion: This study outlines the post-marketing safety profile of ramucirumab, identifying unexpected signals that warrant further investigation, including a newly described subgroup of ramucirumab-induced haemorrhage.