FDA 부작용 보고 시스템 데이터베이스를 이용한 Cyclosporine과 Tacrolimus의주요 약물이상사례 및 실마리 정보 분석
Analysis of Important Medical Adverse Events and Signals Related with Cyclosporine and Tacrolimus Using the FDA Adverse Event Reporting System (FAERS) Database
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Objective: This study aimed to analyze the important medical adverse events (IMEs) of cyclosporine and tacrolimus using thereports in US FDA adverse event reporting system (FAERS) and to detect related signals. Methods: The FAERS database was usedto analyze the IMEs reported for cyclosporine or tacrolimus during 2017-2021. Reporting odds ratio (ROR) and informationcomponent were used to analyze signals for adverse events of both drugs. It was investigated whether the detected signals werepresent on drug labels in Korea and the United States. Results: Among the total 24,688 reports, the reports on tacrolimus accounted75.8%. Mean age of the patients was 47.9 years old and median number of adverse events was 2.0 per report. The number of patientshospitalized for adverse events was 7,979 (25.3%). Among the adverse reactions reported on the cyclosporine and tacrolimus, 576and 1,363 events were detected as signals for cyclosporine and tacrolimus, respectively, and of these, IMEs accounted for 44.8 and59.2%, respectively. The IMEs related with infections/infestations, renal/urinary disorders, and blood and lymphatic systemdisorders were reported frequently for both drugs. The most frequently detected IMEs were renal impairment for cyclosporine andacute kidney injury for tacrolimus. Among the top 3 IMEs for each reported SOC for cyclosporine and tacrolimus, 9 and 2unexpected adverse events were identified, respectively. Conclusion: This study identified the IMEs and signals of cyclosporine andtacrolimus, and detected unidentified adverse events in a drug information database.
Abstract
Objective: This study aimed to analyze the important medical adverse events (IMEs) of cyclosporine and tacrolimus using thereports in US FDA adverse event reporting system (FAERS) and to detect related signals. Methods: The FAERS database was usedto analyze the IMEs reported for cyclosporine or tacrolimus during 2017-2021. Reporting odds ratio (ROR) and informationcomponent were used to analyze signals for adverse events of both drugs. It was investigated whether the detected signals werepresent on drug labels in Korea and the United States. Results: Among the total 24,688 reports, the reports on tacrolimus accounted75.8%. Mean age of the patients was 47.9 years old and median number of adverse events was 2.0 per report. The number of patientshospitalized for adverse events was 7,979 (25.3%). Among the adverse reactions reported on the cyclosporine and tacrolimus, 576and 1,363 events were detected as signals for cyclosporine and tacrolimus, respectively, and of these, IMEs accounted for 44.8 and59.2%, respectively. The IMEs related with infections/infestations, renal/urinary disorders, and blood and lymphatic systemdisorders were reported frequently for both drugs. The most frequently detected IMEs were renal impairment for cyclosporine andacute kidney injury for tacrolimus. Among the top 3 IMEs for each reported SOC for cyclosporine and tacrolimus, 9 and 2unexpected adverse events were identified, respectively. Conclusion: This study identified the IMEs and signals of cyclosporine andtacrolimus, and detected unidentified adverse events in a drug information database.
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