A comprehensive pharmacovigilance study of vision impairment associated with anticoagulants: disproportionality analysis and detection of potential drug-drug interaction signals

Recent concerns have emerged regarding the ocular safety of pentosan polysulfate sodium (PPS) and other anticoagulants. However, their comparative safety profiles remain unclear. Our objective is to evaluate the association between specific anticoagulants, particularly PPS, and vision impairment (VI) using real-world pharmacovigilance data. Data were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Disproportionality analysis utilizing reporting odds ratio (ROR) was conducted to identify ocular safety signals. Subgroup analysis, time-to-onset (TTO) analysis, co-medication analysis, and global assessment of the evidence were used to describe these associations. PPS demonstrated significantly higher ROR of VI compared to heparin (ROR 149.25, 95% CI 127.61 - 174.57, p < 0.0001), low molecular weight heparins (LMWHs) (ROR 161.49, 95% CI 137.95 - 189.04, p < 0.0001), fondaparinux (ROR 181.96, 95% CI 134.54 - 246.09, p < 0.0001), warfarin (ROR 126.68, 95% CI 113.93 - 140.85, p < 0.0001), direct oral anticoagulants (DOACs) (ROR 74.40, 95% CI 70.70 - 78.30, p < 0.0001), bivalirudin (ROR 499.40, 95% CI 187.20 - 1332.27, p < 0.0001), and other glycosaminoglycan (GAG) analogues (ROR 18.66, 95% CI 9.25 - 37.64, p < 0.0001). TTO analysis revealed that PPS-associated VI followed a random failure pattern, with males and younger patients exhibiting earlier onset. No significant drug interactions between PPS and commonly concomitant medications were detected. PPS may be associated with a higher frequency of reported VI compared to other anticoagulants. These findings underline the critical need for drug-specific safety monitoring. Prospective studies are warranted to further elucidate the ocular safety profiles of anticoagulants, particularly PPS. Not applicable.