Signal mining and analysis of adverse drug events for tolvaptan based on FAERS database / 中国药房

ABSTRACT

OBJECTIVE To mine the signals of adverse dr ug events （ADE）for tolvaptan based on FAERS database ，and to provide reference for safe use of drugs in clinic. METHODS The data of tolvaptan-induced ADE were collected from FAERS database during the first quarter of 2004 to the third quarter of 2020；the reporting odds ratio （ROR）method and the proportional reporting ratio （PRR）method of disproportional method were used for data mining. RESULTS A total of 4 744 ADE reports of the target drug tolvaptan were extracted ，involving 1 279 ADEs. The reporting countries were mainly the United States and Japan ，etc. A total of 199 ADE signals were obtained ，involving 21 system organ classes （SOCs），which mainly focused on various examinations（n＝56），hepatobiliary disorders （n＝17），renal and urinary disorders （n＝14），etc. Among them ，80 signals were not mentioned in existing instructions for tolvaptan in China ，such as decreased glomerular filtration rate ，positional vertigo ， rupture of renal cyst ，renal cyst infection ，pulmonary malignant tumor. CONCLUSIONS Before using tolvaptan ，drug evaluation should be performed well ，especially the patients with basic diseases such as heart failure ，liver insufficiency and renal insufficiency. During treatment ，the indexes of liver function and renal function should be closely monitored ；timely intervention measures should be taken to avoid related injury and disease deterioration caused by ADE when ADE or disease progression occurs.