Pharmacovigilance study reveals disproportionate retroperitoneal fibrosis reports across multiple drug classes, highlighting potential medication triggers.
Key Points
To identify and quantify signals of disproportionate reporting for drug-associated retroperitoneal fibrosis using the FDA Adverse Event Reporting System.
Queried the FAERS database spanning 1969 to 2025 across a total of 30,668,520 adverse event reports.
Identified drugs with more than 20 retroperitoneal fibrosis reports to perform disproportionality analysis.
Calculated reporting odds ratios (ROR), proportional reporting ratios (PRR), 95% confidence intervals, and chi-square values, defining significance as PRR > 2, chi-square > 4, and p < 0.05.
A total of 1,013 retroperitoneal fibrosis reports were identified, with 392 (38.7%) linked to eleven drugs exceeding the 20-case threshold.
The strongest reporting signals were detected for methysergide (ROR: 5332.28; 95% CI: 4292.96–6623.21; PRR: 4604.65; p < 0.0001), pergolide (ROR: 923.85; 95% CI: 686.60–1243.09; PRR: 897.76; p < 0.0001), and bromocriptine (ROR: 311.30; 95% CI: 224.78–431.13; PRR: 308.26; p < 0.0001).
Significant disproportionality signals (all p < 0.0001) were also identified for bisoprolol, atenolol, metformin, etanercept, prednisone, rituximab, propranolol, and cyclophosphamide.