Systemic Drugs Associated With Maculopathy

Area of Science:

• Ophthalmology
• Pharmacovigilance
• Drug Safety

Background:

• Systemic medications can cause unrecognized macular toxicity, necessitating early identification for vision preservation.
• Identifying drugs with potential macular adverse effects is crucial for patient safety.

Purpose of the Study:

• To identify systemic drugs potentially associated with maculopathy using pharmacovigilance data.
• To evaluate the macular adverse effects of identified drugs in a large-scale population database.

Main Methods:

• A two-part study involving disproportionality analysis of FAERS (Food and Drug Administration Adverse Event Reporting System) data for signal identification.
• A population-based cohort study using the South Korean Health Insurance Review and Assessment Service (HIRA) database to evaluate associations.

Main Results:

• Five systemic drugs (fingolimod, apixaban, paclitaxel, ibrutinib, sildenafil) were identified as potential maculopathy signals in FAERS.
• Increased maculopathy incidence rates were observed for apixaban (3.08), paclitaxel (2.85), ibrutinib (3.71), and sildenafil (2.75) in the HIRA database.
• Dose-response relationships were noted for paclitaxel and ibrutinib, suggesting increased risk with higher exposure levels.

Conclusions:

• The integrated approach of pharmacovigilance and health claims analysis successfully identified associations between maculopathy and several systemic drugs.
• This combined methodology provides a cost-effective and robust strategy for detecting systemic drugs with potentially underrecognized macular adverse effects.