Signal mining and analysis of adverse events of roxadustat based on the JADER database
Objective To detect adverse event signals of roxadustat based on the JADER database and evaluate its safety in the real world,so as to provide evidence for rational use of medicines.Methods The adverse event reports from April 2004 to August 2024 were collected.The adverse event signal were analyzed using the reporting odds ratio method and comprehensive standard method.Results A total of 2 997 adverse event reports related to roxadustat as"suspected"were collected.There was a slightly higher proportion of males.The age was mainly concentrated between 65 and 84 years.A total of 101 adverse event signals were identified.The signals with high frequency were consistent with the instruction basically,including hypothyroidism,cerebral infarction,deep vein thrombosis,hyperkalemia,etc.Additionally,some new suspicious adverse reactions were discovered,such as jaundice,hyperbilirubinemia,retinal hemorrhage,etc.Conclusion In clinical practice,healthcare professionals should pay attention to patients'thyroid function indicators,cardiovascular and cerebrovascular function,blood potassium levels,as well as infection symptoms and signs,and be alter to the adverse event signals not mentioned in the instruction to ensure patient safety.
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