Adverse event signal mining and analysis of Anakinra based on FAERS database
Objective The adverse event signal of Anakinra were mined to provide references for safe and rational clinical drug use.Methods Adverse event data from the establishment of FAERS database to the fourth quarter of 2023 were extracted,and the suspicious risk signals of Anakinra were mined by utilizing the reporting odds ratio(ROR)method and Bayesian confidence propagation neural network method(BCPNN).Results A total of 7 428 AE reports were obtained,of which gender predominantly male(64.9％)and country of reporting predominantly US(63.57％).A total of 174 risk signals were detected,involving 21 systems and organ classifications(SOC),mainly General disorders and administration site conditions(4 362 cases,40.11％),Injury,poisoning and procedural complications(3 722 cases,34.22％).The more frequent PT included off-label use,injection site reactions,etc.Newly found suspected adverse reactions include hepatobiliary system related adverse reactions,chickenpox,etc.After excluding the reports of consumers and unknown professionals,the analysis results are the same as above.Conclusions Anakinra related PT signals are widely involved in SOC,so standardized clinical use management and off-label use management of Anakinra should be strengthened,medical staff should help patients to overcome injection site reactions and enhance medication compliance,and the influence of drugs on relevant laboratory indicators should be considered in clinical application.Anakinra should be used with caution when treating patients with infectious diseases and immunocompromised patients.At the same time,we should be alert to hepatobiliary related adverse reactions.
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