Ocular adverse events associated with platins: a disproportionality analysis of pharmacovigilance data and extensive systematic review of case reports.

Abstract

Background: Anti-cancer drugs, particularly platinum-based chemotherapy drugs, have been showing ocular adverse events (OAEs) in patients undergoing chemotherapy, which is concerning due to the potential impact on patient's quality of life and the ability to continue effective cancer treatment.

Research design and methods: A retrospective case/non-case study was conducted using spontaneous reports on OAEs by platins from the FDA Adverse Event Reporting System (FAERS) database. A disproportionality analysis was performed by calculating the Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), and the Information Component (IC) to identify OAE signals for platinum-based chemotherapy drugs. In parallel, a review of case reports for OAEs from platins was conducted by a systematic literature search in PubMed and Google Scholar.

Results: Using disproportionality analysis, 69 signals were identified for platinum-based chemotherapy drugs and OAEs (carboplatin: 42, oxaliplatin: 16, cisplatin: 11). Choroidal infarction [PRR = 215.1; χ² = 4527.1; lower bound (LB) ROR = 140.7; IC₀₂₅ = 5.1] and orbital hemorrhage [PRR = 120.0; χ² = 300.5; LB ROR = 35.1; IC₀₂₅ = 1.3] were the strong signals identified for carboplatin. Optic disc hyperemia [PRR = 208.2; χ² = 742.5; LB ROR = 74.1; IC₀₂₅ = 2.2] and blindness cortical [PRR = 23.7; χ² = 382.5; LB ROR = 14.8; IC₀₂₅ = 3.1] were the signals identified for oxaliplatin and cisplatin, respectively. A total of 32 case reports of OAEs from platinum-based chemotherapy drugs were identified through a systematic search in PubMed and Google Scholar, strengthening the association.

Conclusion: The study revealed a potential risk of OAEs when using platinum-based chemotherapy drugs as an anticancer medication.