Data Mining of Azathioprine Related Death Events Based on FDA Adverse Event Report System / 中国药房

ABSTRACT

OBJECTIVE： To mine the data of azathioprine related death events based on FDA Adverse Event Report System （FAERS）， and to provide reference safe use of azathioprine in clinic. METHODS： Totally 60 quarters of FARES data were downloaded from 2004Q1 to 2018Q4. After drug names standardized by Medex_UIMA_1.3.7 and adverse events classified by MedDRA， death events related to azathioprine were extracted. The safety signals were detected by using ROR and PRR methods. The death events related to azathioprine were analyzed in respects of patient’s general information， reporter’s information， time and country distribution of reports， signal detection results， dose and drug combination of direct and indirect death， reported frequency of indirect deaths. RESULTS： A total of 39 695 azathioprine related death events were gathered， including 707 direct death reports and 3 219 indirect death reports. The media age was 55 years in dead. Physicians and other health professionals reports took up 77.38％. Azathioprine administered orally took up 90.40％ （647/715） in reported cases of known route of adiministration. “Fetal death” （ROR＝4.16， PRR＝4.16） and “neonatal death” （ROR＝4.99， PRR＝4.99） were detected as signal. About 30 percent of the death reports were the old patients. There were cases using azathioprine beyond contraindications or maximum dosage. Among drug combination， immunosuppressive drugs were used most frequently. Infection events were reported most frequently in indirect deaths （3 122 reports）. CONCLUSIONS： The potential death risk of azathioprine should be paid attention to， and the contraindications and dosage of azathioprine should be strictly controlled. Great importance should be paid attention to medication for special population of the elderly and children. It is suggested that genetic testing and precise drug use should be perfected before using azathioprine.