Systemic Drugs Associated With Maculopathy

Are there systemic drugs associated with potentially underrecognized maculopathies identified using pharmacovigilance signal detection and nationwide health claims analyses?In this study, US Food and Drug Administration Adverse Event Reporting System (FAERS) disproportionality analysis of 15 748 maculopathy reports identified fingolimod, apixaban, paclitaxel, ibrutinib, and sildenafil as candidate signals. With the use of South Korean Health Insurance Review and Assessment Service databases, apixaban, paclitaxel, ibrutinib, and sildenafil were shown to have elevated incidence rate ratios and cumulative maculopathy incidence rates ranging from 6.0% to 15.7%, with dose-dependent risk increases for paclitaxel and ibrutinib.By integrating FAERS pharmacovigilance data with nationwide health claims, the cohort study revealed underrecognized maculopathy risks, supporting monitoring for maculopathies associated with drug use.

Corresponding Authors: Seong Joon Ahn, MD, PhD, Department of Ophthalmology, Hanyang University Hospital, Hanyang University College of Medicine, 222-1 Wangsipli-ro, Seongdong-gu, Seoul 04763, Republic of Korea (ahnsj81@gmail.com); Jee-Eun Chung, RPh, PhD, College of Pharmacy and Institute of Pharmaceutical Science and Technology, Hanyang University, 55 Hanyangdaehak-ro, Sangnok-gu, Ansan, 15588, South Korea (jechung@hanyang.ac.kr).

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