Data Mining and Analysis of Amiodarone Related Adverse Drug Events of Blindness Based on FAERS

OBJECTIVE To carry out the signal mining of adverse drug events(ADE) related to amiodarone based on FAERS, and to explore the occurrence characteristics of related blind ADE and the correlation between amiodarone and related blind ADE. METHODS Reporting odds ratio methods and medicines and healthcare products regulatory agency methods were used to mine the amiodarone related ADE of blindness based on the ADE report data of 24 quarters from the first quarter of 2016 to the fourth quarter of 2021 extracted from the FAERS. After valid signals were obtained, the MedDRA was used for translation and system organ classification. RESULTS A total of 39 166 amiodarone related reports were obtained, 503 amiodarone related ADEs of blindness were reported. Among them, the four preferred terms of blindness, unilateral blindness, amaurosis, and amaurosis transient used both methods to prompt the generation of suspicious signals. Among the 503 patient reports, the proportion of male(64.41%) was higher than that of female(31.22%), and among the patients of known age, the age was mainly concentrated in those ≥ 65 years old(6.16%). The reporters were mainly lawyers and consumers(90.46%), and the proportion of medical staff was relatively low; except for patients whose route of administration was unknown, all the patients were administered orally(66.80%). The median onset time of amiodarone-related blindness adverse events was 692 d(interquartile range 422.5-1 045.75 d); the highest proportion of patient outcomes was other serious medical events. A total of 279 cases (55.47%) were reported. There were 73 reported cases(14.51%) with the outcome of death, ranking the third. CONCLUSION Attention should be paid to the risk of blindness of amiodarone, focusing on males, elderly people over 65 years old, and patients with oral administration. Strengthen ophthalmic evaluation before medication and ocular monitoring during and after medication. Timely diagnosis and treatment can prevent occurrence of blindness related ADE.