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Systemic Drugs Associated With Maculopathy.

Jiyeong Kim1, Seong Joon Ahn2, Jiyeon Park3

  • 1Department of Pre-Medicine, College of Medicine, and Biostatistics Laboratory, Medical Research Collaborating Center, Hanyang University, Seoul, Republic of Korea.

JAMA Ophthalmology
|October 23, 2025
PubMed
Summary
This summary is machine-generated.

This study identified five systemic drugs, including apixaban, paclitaxel, ibrutinib, and sildenafil, linked to maculopathy. Combining pharmacovigilance and health claims data offers a robust method for detecting drug-induced macular toxicity.

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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.