Ocular adverse events associated with Platins: a disproportionality analysis of pharmacovigilance data and extensive systematic review of case reports
Creators: name: Hasik, Pn
name: Thomas, Christy
name: Hazarika, Munlima
name: Undela, Krishna
Publisher: name: Taylor & Francis
Year: 2024
Subjects: Medicine
Pharmacology
Biotechnology
Chemical Sciences not elsewhere classified
Cancer
Science Policy
Mental Health

description: 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. 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. 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; χ<sup>2</sup> = 4527.1; lower bound (LB) ROR = 140.7; IC<sub>025</sub> = 5.1] and orbital hemorrhage [PRR = 120.0; χ<sup>2</sup> = 300.5; LB ROR = 35.1; IC<sub>025</sub> = 1.3] were the strong signals identified for carboplatin. Optic disc hyperemia [PRR = 208.2; χ<sup>2</sup> = 742.5; LB ROR = 74.1; IC<sub>025</sub> = 2.2] and blindness cortical [PRR = 23.7; χ<sup>2</sup> = 382.5; LB ROR = 14.8; IC<sub>025</sub> = 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. The study revealed a potential risk of OAEs when using platinum-based chemotherapy drugs as an anticancer medication. The study aimed to investigate the risk of ocular adverse events (OAEs) associated with platinum-based chemotherapy drugs, namely cisplatin, carboplatin, and oxaliplatin. Analyzing data from pharmacovigilance databases and conducting a systematic review of case reports to identify and understand these potential risks. Their Pharmacovigilance analysis revealed many reports detailing OAEs related to these platinum-based drugs. Notable findings included signals indicating serious adverse events such as blindness, retinal toxicity, and optic nerve damage. Further refinement of these signals, considering the influence of concurrent medications, confirmed the association between platinum drugs and OAEs. Additionally, the systematic review of case reports provided insights into specific OAEs observed in patients receiving platinum-based chemotherapy. Common adverse events included vision impairment, retinal issues, and tunnel vision, with some patients experiencing irreversible vision loss. The study highlighted the importance of recognizing and monitoring OAEs in platinum-based chemotherapy patients. It emphasized the need for healthcare providers to assess patients’ ocular histories carefully before treatment and for regulatory authorities to incorporate relevant findings into drug safety guidelines. Overall, the research enhances patient care and safety in cancer treatment by providing comprehensive information on the ocular toxicity associated with platinum-based chemotherapy drugs.