Study on the data mining and analysis of amiodarone-related optic nerve adverse events based on FAERS database
Objective Based on FAERS database,signal mining of amiodarone related optic nerve adverse events was conducted to explore the correlation and occurrence characteristics between amiodarone and optic nerve adverse events,providing a reference basis for the safety of amiodarone administration.Methods By retrieving the amiodarone-related optic nerve adverse event reports from the FAERS database between January 2004 and December 2022,four signal detection methods were utilized,including the Reporting Odd Ratio(ROR),Medicines and Healthcare Products Regulatory Agency(MHRA),Bayesian Confidence Propagation Neural Network(BCPNN)and Multiple Item Empirical Bayesian Gamma-Poisson Shrinker(MGPS).Results The number of reports with amiodarone as the primary suspected drug was 17 234,reporting a total of 69 727 adverse event occurrences,including 282 reports and 397 cases of optic nerve adverse events.Signal detection showed a suspicious signal between amiodarone and optic nerve adverse events,indicating that amiodarone was associated with optic nerve adverse events(ROR=14.59,95%CI=13.21 to 16.12).Among the reports,73.76%were males,21.28%were females,39.01%of the patients were aged 65 or above,52.84%were administered orally,and 2.13%were administered by injection.The median induction time for amiodarone-related optic nerve adverse events was 143 days.Disability,such as blindness,accounted for 31.20%of the patients'prognostic outcomes.There were gender differences in the signal detection of amiodarone-related optic nerve adverse events,with males being more likely to experience ischemic optic neuropathy(ROR=2.79,95%CI=1.69 to 4.59)and optic nerve damage(ROR=3.59,95%CI=1.50 to 8.57).Conclusion There is a correlation between amiodarone and the occurrence of optic nerve adverse events,and there is a gender difference in the signal of adverse events,and the administration of amiodarone may increase a patient's risk of optic nerve-related adverse events.Clinical use of amiodarone should enhance ophthalmologic examination of long-term oral drug users,the elderly,and male patients for timely intervention.
万方数据
维普
