Pharmacovigilance on Dexamethasone 1 mg/mL + Levofloxacin 5 mg/mL Eye Drops, Solution: A Five-Year Registry

Abstract

Cataract surgery is a common procedure requiring post-surgical pharmacological treatment to dampen inflammation and prevent infections. In 2020, a fixed eye drops combination of dexamethasone 1 mg/mL + levofloxacin 5 mg/mL for prevention and treatment of inflammation, and prevention of infection associated with cataract surgery in adults was approved. This innovative combination ensures the control of inflammation and prevents infection in a one-week course, preventing antibiotic resistance and minimizing steroid adverse events. This study aimed to collect information on reported suspected Adverse Drug Reactions (ADRs) of this product and analyze their characteristics in various System Organ Classifications. Using the European database of suspect ADRs as an access tool, we extracted line listings of reported ADRs that occurred using levofloxacin/dexamethasone from 2020 to 2024. The product has been approved in almost sixty countries worldwide, and approximately 4 million patients have been treated. A total of 53 ADRs concerning 25 patients were retrieved: 39 ADRs were not serious, while 14 ADRs were serious; 27 ADRs (51%) were evaluated as unlikely related to the drug. Eye and skin were the most common systems involved. Moreover, 15 special situations have been registered, mostly off-label use (10; 67%). Interestingly, levofloxacin/dexamethasone was not associated with confirmed endophthalmitis occurrence, one of the most serious ophthalmic emergencies. Based on data collected, no relevant safety issues have been identified that would alter the product's safety and efficacy profile. A large proportion of these ADRs were non-serious and unlikely to be related to the product or special situations.