ABSTRACT
OBJECTIVE To explore the risk signals of Fluocinolone acetonide intravitreal implants and promote safe and rational drug use for patients. METHODS Based on the data from the Hainan Province Franchised Drug Adverse Reaction Monitoring Subsystem （hereinafter referred to as the “Franchised Drug Monitoring System”） and the FDA Adverse Event Reporting System （FAERS）， the adverse drug reaction （ADR）/adverse drug event （ADE） reports of Fluocinolone acetonide intravitreal implants were coded by using system organ classification and preferred terminology， and relevant patient information was collected. Risk signal mining was carried out by using the reporting odds ratio （ROR） method and the comprehensive standards method of the UK Medicines and Healthcare Products Regulatory Agency （hereinafter referred to as the “MHRA method”）. RESULTS Among the 72 reports of Fluocinolone acetonide intravitreal implants received by the Franchised Drug Monitoring System， the ratio of male to female was 1∶1.4， the patient’s age was mainly distributed between 18 and 64 years old； ADR/ADE affected 5 systemic organs， with eye organ diseases accounting for 87.7%； among them， there were 9 new and general ADR reports （12.5%） and 4 severe ADR reports （5.6%）； ROR method and MHRA method both identified three risk signals： cataracts， glaucoma， and high intraocular pressure. Among the 244 reports received by the FAERS database， the ratio of male to female was 1∶1.5； ADR/ADE damage affected 10 systemic organs， with 46.1% suffering from various injuries， poisoning， and operational complications， and 32.0% suffering from product problems； there were 20 severe ADR reports （8.2%）； ROR method and MHRA method both identified 19 risk signals， including implantation complications， medication system issues， etc. CONCLUSIONS When using Fluocinolone acetonide intravitreal implants in clinical practice， in addition to paying attention to eye ADR/ADE such as high intraocular pressure， cataracts， and glaucoma， attention should also be paid to the potential risks caused by ADE due to product quality and unreasonable use.