Adverse events associated with cefuroxime ocular administration: potential demographic and dose-dependent...

Cefuroxime ocular administration is widely used to reduce the incidence of endophthalmitis after ocular surgery. However, due to ocular administration not being the recommended route in the prescribing information for cefuroxime, there is still a lack of systematic research on the adverse events of cefuroxime ocular administration. This study evaluated the adverse events following cefuroxime ocular administration using the FDA Adverse Event Reporting System database, with particular focus on the potential heterogeneity of reporting adverse events across different populations and dosing regimens.

The clinical characteristics of cefuroxime ocular administration-associated adverse event reports were analyzed and significant adverse event signals were identified using four disproportionality methods. Then, the potential demographic and dose-dependent differences in reporting adverse events were studied using the reporting odds ratio algorithm and Fisher's exact test.

88.7% of the adverse event cases resulted in severe outcomes. Sixteen signals for "eye disorders" and three signals for "injury, poisoning and procedural complications" were identified. There may be potential difference in reporting cefuroxime ocular administration-associated adverse events across continents, sexes and doses.

This study emphasizes the need for careful attention to eye disorders and stringent quality control measures for off-label use when cefuroxime was administered ocular. The findings underscore the need for future confirmatory studies into the potential demographic and dose differences in adverse events associated with cefuroxime ocular administration. The findings represent hypothesis-generating associations which require further validation.What is already known on this topicCefuroxime ocular administration during ocular surgeries significantly reduces postoperative intraocular inflammation.Previous research highlighted a significant disproportionality of eye disorders after post-marketing of cefuroxime.Due to ocular administration not being the recommended route, there is still a lack of systematic research on the adverse events of cefuroxime ocular administration. What this study addsThis represents a pharmacovigilance study to evaluate cefuroxime ocular administration-associated adverse events.88.7% of the cases resulted in severe outcomes.There may be potential difference in reporting cefuroxime ocular administration-associated adverse events across continents, sexes and doses. How this study might affect research, practice or policyThis study emphasizes the need for careful attention to ocular adverse events when cefuroxime was administered ocular.The findings underscore the need for future confirmatory studies into the potential demographic and dose differences in adverse events associated with cefuroxime ocular administration.