Analysis of adverse drug events of nafamostat by using Japanese adverse drug event report database
AIM For clinical safety and rational use of nafamostat(NM),the state and characteristics of adverse events of NM in Japan were analyzed and reported.METHODS The NM adverse drug event(ADE)received from the first quarter of 2012 to July 2023 were downloaded from the Japanese adverse drug event report(JADER)database,and the repeated and non-causal cases were removed.The gender,age,type of primary disease,reason for administration,drug dose of administration,recovery and other information were recorded and analyzed to compare the differences between off-label indication ADE and other ADE outcomes.RESULTS After excluding the repeated and non-causal cases,a total of 762 ADEs were obtained.489 cases were male,and 581 cases were over 60 years old,most of whom had underlying diseases and the main purpose of medication was anticoagulation for extracorporeal circulation.A single dose of 10-49 mg was the largest proportion followed by 100-199 mg.Routes of administration were mainly intravenous and hemodialysis.The main outcomes were recovery and improvement.Among the deceased patients,11 cases were determined to have a causal relationship with ADE in the JADER database,while the remaining 25 cases were possibly unrelated or inconclusive.The most common ADEs were anaphylactic shock,anaphylactoid shock,anaphylactic reaction,anaphylactoid reactions and hypersensitivity reactions,shock and low blood pressure The system organ class mainly involved was immune system disease,In cases suspected to involve only NM as a single drug,after excluding cases of cardiopulmonary extracorporeal circulation with intravenous administration,there was no statistical difference in outcomes between off-label indication ADEs and other ADEs(P＞0.05).CONCLUSION The most common symptom of ADE caused by NM is allergy-related symptoms,and it is recommended that skin test should be considered besides asking about allergic history before medication.In addition,the frequent occurrence of hypotension should be noted,which exceeds the frequency of hyperkalemia ADE reported in previous literature.
nafamostatadverse drug eventJapanese adverse drug event reportanaphylactoid reactionanaphylactic reaction
国家科技期刊平台
NSTL
万方数据
