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Bisphosphonates and glaucoma: a pharmacovigilance signal detection analysis using the FAERS database
Yan Zhang1, Yi Hong Huang1, Yan Ling Xiao1
1Department of Ophthalmology, Second Affiliated Hospital of Fujian Medical University, Quanzhou, China; Engineering Research Centre of Assistive Technology for Visual Impairment, Fujian Medical University, Fuzhou, Fujian, China.
Summary
This study found specific bisphosphonates linked to different glaucoma types in adverse event reports. These safety signals require further investigation into their clinical and mechanistic basis.
Area of Science:
- Pharmacovigilance
- Ophthalmology
- Drug Safety
Background:
- Bisphosphonates are commonly prescribed for osteoporosis and other bone conditions.
- Glaucoma is a group of eye conditions that damage the optic nerve, often associated with intraocular pressure.
- Previous research has suggested potential links between bisphosphonate use and ocular adverse events, but specific associations with glaucoma subtypes remain unclear.
Purpose of the Study:
- To identify and characterize potential disproportionality signals between individual bisphosphonates and various glaucoma subtypes.
- To analyze adverse event data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) for these associations.
Main Methods:
- A retrospective pharmacovigilance disproportionality analysis was conducted using FAERS data from Q1 2004 to Q1 2025.
- Statistical methods included reporting odds ratio (ROR), proportional reporting ratio (PRR), and Bayesian confidence propagation neural network (BCPNN).
- Significant signals were defined by specific thresholds for case counts and statistical measures, with adverse events coded using the Medical Dictionary for Regulatory Activities.
Main Results:
- Significant disproportionality signals were observed for alendronic acid and pamidronic acid at the group level.
- Specific subtype associations included alendronic acid with open-angle and normal-tension glaucoma, pamidronic acid with open-angle glaucoma, and risedronic acid with angle-closure glaucoma.
- Median time-to-onset for these events varied considerably, ranging from 10 to 1579 days.
Conclusions:
- Distinct disproportionality signals link specific bisphosphonates to different glaucoma subtypes.
- The identified safety signals suggest a need for further clinical and mechanistic research.
- Heterogeneous time-to-onset patterns were noted, emphasizing the complexity of these potential drug-induced effects.
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