ADE signal mining and analysis of axitinib based on FAERS database
- VernacularTitle:基于FAERS数据库的阿昔替尼ADE信号挖掘与分析
- Author:
Runan XIA
1
,
2
,
3
;
Ting YING
1
,
3
;
Hai LIANG
2
;
Jiahui DAI
1
,
3
;
Yadong WANG
1
,
3
;
Xuefeng XIE
1
Author Information
1. School of Pharmacy，Anhui Medical University，Hefei 230031，China
2. Dept. of Pharmacy，Bozhou Hospital Affiliated to Anhui Medical University，Anhui Bozhou 236800，China
3. Anhui Provincial Key Laboratory of Philosophy and Social Sciences for Public Health and Social Governance，Hefei 230031，China
- Publication Type:Journal Article
- Keywords:
axitinib;
adverse drug event;
data mining;
proportional imbalance measurement;
US FDA Adverse Event
- From:
China Pharmacy
2023;34(23):2896-2900
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To provide references for the clinical safe use of axitinib. METHODS Adverse drug event （ADE） data for axitinib were collected from the US FDA Adverse Event Reporting System （FAERS） database from the first quarter of 2012 to the fourth quarter of 2022. The data were mined and analyzed by utilizing the ratio-of-reporting-ratio （ROR） method and comprehensive standard method of the United Kingdom’s Medicines and Healthcare Products Regulatory Agency （MHRA） of proportional imbalance measurement. RESULTS A total of 13 962 reports of axitinib-related ADEs were obtained， with patients’ age concentrated in 65-85 years （43.25%）， gender predominantly male （65.23%）， country of reporting predominantly US （60.01%）， and serious ADE outcomes mostly hospitalization or prolonged hospitalization （31.51%）. A total of 172 ADE risk signals were detected， involving 18 system and organ classifications （SOC）， mainly systemic diseases and various reactions at the site of administration （3 749 cases， 30.84%） and gastrointestinal system diseases （2 067 cases， 17.00%）. ADE risk signals that occurred more frequently were generally consistent with the drug instruction， such as diarrhea， fatigue， and hypertension； new ADE risk signals requiring clinical attention were death， immune-mediated nephritis， and PT signals contained in the SOC of various benign， malignant， and tumors of undetermined nature （including cysts and polyps）. CONCLUSIONS For ADEs that occur frequently with axitinib and are already contained in the drug instruction （e.g. hypertension， diarrhea）， they should be adequately evaluated before administration， especially for patients with combined use of immune checkpoint inhibitors and patients with underlying hypertension； for ADEs with stronger signals and newer ADEs （e. g. death， disease progression， tumor progression）， the patient’s disease progression should be closely monitored during the treatment period for potentially fatal ADEs； for its rare ADEs （e. g.immune-mediated nephritis， scrotal ulcer， non-infectious encephalitis）， clinical validation should be further strengthened.
