ADR Signal Mining of Rivaroxaban Based on FDA Adverse Event Reporting Database / 中国药房

ABSTRACT

OBJECTIVE：To excavate the ADR signals of rivaroxaban and provide reference for its safe and rational use in clinic. METHODS ：Based on FDA adverse event reporting system （FAERS），the ADRs of rivaroxaban reported from September 2008 to December 2020 in FDA ’s Open Data Program were mined using ratio of reports to odds （ROR）and proportional report ratio （PRR）. The related ADRs were analyzed ，and the corresponding system organ classification （SOC）was mapped. At the same time，the basic information such as gender ，age and indications of the patients were statistically reported. RESULTS & CONCLUSIONS：Among 9 373 236 ADR reports extracted ，102 027 ADR reports with rivaroxaban as concomitant and suspected drug were obtained ；883 ADR signals were mined ，involving 27 systems. Among 102 027 reports，the proportion of female patients （41 294 cases，40.47％）was similar to that of male patients （41 071 cases，40.26％）. The patients were mainly ＞50 to 75 years old（29 261 cases，28.68％）and ＞75 years old （21 470 cases，21.04％）. The reporting year was mainly in 2018（18 446 cases， 18.08％）；main reporting country was the United States （75 390 cases，73.89％）；there were 35 046 cases（34.35％）of severe ADR reports ，mainly involving hospital or prolonged hospital stay. The SOC of rivaroxaban ADR singal mainly focused on diseases of the blood and lymphatic system ，vascular diseases ，various types of examination and nervous system diseases. Among top 20 preferred terms of ADRs with the highest frequency ，except for pulmonary embolism ，acute kidney injury and atrial fibrillation ，the rest were mainly bleeding related ADRs ，of which intracranial hemorrhage was the more seriou s ADR. Intracranial hemorrhage may occur when rivaroxaban is used for the prevention of atrial fibrillation and cerebrovascular accidents ， and pulmonary embolism may occur when rivaroxaban is used for the prevention of pulmonary embolism ，（deep）venous thrombosis and thrombosis. Great importance should be paid on it.