Topical ophthalmic beta‐blockers are associated with ocular pseudopemphigoid: A pharmacovigilance study of antiglaucoma medications utilising the FDA adverse event reporting system

Abstract

ABSTRACTBackground/objectiveThe association between antiglaucoma medications and the development of ocular pseudopemphigoid (OPP) has been described; however, the independent risk of each medication has not been quantified.MethodsCase/non‐case analyses were performed in the FDA Adverse Events Reporting System (FAERS) using data from 2010–2020 to examine the reporting odds ratio (ROR) signal for OPP for all classes of antiglaucoma medications under multiple conditions: (i) comparison to all other drugs in FAERs, (ii) comparison to other antiglaucoma medications, (iii) comparison to vehicle/hydrating eye drops with cases of OPP and (iv) comparison to vehicle/hydrating eyedrops with and without cases of OPP to control for topical irritant and preservative effects.ResultsA statistically significant ROR for OPP was found for aggregate antiglaucoma medications under the first condition but not the third or fourth (i.96.97 (95% CI 52.54–178.98). The largest signal for OPP when compared to other glaucoma drugs and eye drops was seen with unoprostone (ii.68.96 (95% CI 8.35–569.50, iii.39.85 (95% CI 4.14–383.33), iv.581.67 (95% CI 49.38–6851.57) followed by carteolol (ii.32.51(95% CI 9.02–117.67), iii.10.67 (95% CI 1.77–64.13), iv.77.84 (95% CI 12.95–467.78) and betaxolol (ii.23.38 (95% CI 7.28–74.46), iii.6.94 (95% CI 1.27–38.01), iv.50.67 (95% CI 9.26–277.25). A statistically significant ROR was noted only for the beta‐blockers class aggregate under conditions ii and iv.ConclusionsOur findings support an association between OPP and antiglaucoma medications; under the most stringent control for topical irritant/preservative effect by of comparison to topical eye drops, unoprostone, carteolol, betaxolol and timolol all had a significant ROR for OPP.