Bisphosphonates and glaucoma: a pharmacovigilance signal detection analysis using the FAERS database.
Zhang Yan Y, Huang Yi Hong YH, Xiao Yan Ling YL, Zhu Xin Xing XX et al.
To detect and characterize disproportionality signals between individual bisphosphonates and glaucoma subtypes using the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). A retrospective pharmacovigilance disproportionality analysis. Participant data were drawn from adverse event reports from the FAERS database (Q1 2004-Q1 2025). Disproportionality analysis was conducted using the reporting odds ratio (ROR), proportional reporting ratio (PRR), and Bayesian confidence propagation neural network (BCPNN). Adverse events were coded using Medical Dictionary for Regulatory Activities (version 27.1). A significant signal required ≥3 cases and meeting thresholds (ROR 95% CI lower limit >1, PRR ≥2 with χ² ≥4, or BCPNN IC025 >0). Among 539 reports, significant disproportionality signals were identified for alendronic acid (ROR = 2.42; 95% CI: 2.18-2.70) and pamidronic acid (ROR = 2.23; 95% CI: 1.69-2.93) at the group level. Subtype-level signals included alendronic acid with open-angle glaucoma (ROR = 5.67) and normal-tension glaucoma (ROR = 4.60); pamidronic acid with open-angle glaucoma (ROR = 8.62); and risedronic acid with angle-closure glaucoma (ROR = 2.93). Median time-to-onset varied from 10 days (risedronic acid) to 1579 days (pamidronic acid). This pharmacovigilance analysis identifies distinct disproportionality signals linking specific bisphosphonates to different glaucoma subtypes, with heterogeneous time-to-onset patterns. The findings highlight potential safety signals warranting further clinical and mechanistic investigation.