NHC Key Laboratory of Male Reproduction and Genetics, Guangdong Provincial Reproductive Science Institute (Guangdong Provincial Fertility Hospital), Guangzhou, China.
Xiamen Health and Medical Big Data Center, Xiamen, China.
Braz J Med Biol Res. 2024 Jul 29;57:e13392. doi: 10.1590/1414-431X2024e13392. eCollection 2024.
Cyclosporine is an immunosuppressant used to prevent organ rejection in kidney, liver, and heart allogeneic transplants. This study aimed to assess the safety of cyclosporine through the analysis of adverse events (AEs) related to cyclosporine in the US Food and Drug Administration Adverse Event Reporting System (FAERS). To detect AEs associated with cyclosporine, a pharmacovigilance analysis was conducted using four algorithms on the FAERS database: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayes geometric mean (EBGM). A statistical analysis was performed on data extracted from the FAERS database, covering 19,582 case reports spanning from 2013 to 2022. Among these cases, 3,911 AEs were identified, with 476 linked to cyclosporine as the primary suspected drug. Cyclosporin-induced AEs targeted 27 System Organ Classes (SOCs). Notably, the highest case at the SOC level included eye disorders, injury, poisoning, and procedural complications, as well as immune system disorders, all of which are listed on the cyclosporine label. Furthermore, we discovered novel potential AEs associated with hepatobiliary disorders, among others. Moreover, unexpected adverse drug reactions (ADRs), such as biliary anastomosis complication and spermatozoa progressive motility decrease, were identified. Importantly, these newly identified ADRs were not mentioned on the cyclosporine label, which were involved in injury, poisoning, and procedural complications, and investigations at the SOC level. The study used pharmacovigilance analysis of FAERS database to identify new and unexpected potential ADRs relating to cyclosporine, which can provide safety tips for the safe use of cyclosporine.
环孢素是一种免疫抑制剂，用于预防肾、肝和心脏同种异体移植中的器官排斥。本研究旨在通过分析美国食品和药物管理局不良事件报告系统（FAERS）中与环孢素相关的不良事件（AE）来评估环孢素的安全性。为了检测与环孢素相关的 AE，我们在 FAERS 数据库上使用了四个算法（报告比值比（ROR）、比例报告比值（PRR）、贝叶斯置信传播神经网络（BCPNN）和经验贝叶斯几何均值（EBGM））进行药物警戒分析。对从 FAERS 数据库中提取的数据进行了统计分析，该数据库涵盖了 2013 年至 2022 年的 19582 例病例报告。在这些病例中，确定了 3911 例 AE，其中 476 例与作为主要可疑药物的环孢素有关。环孢素引起的 AE 针对 27 个系统器官类别（SOC）。值得注意的是，SOC 水平上最高的病例包括眼部疾病、损伤、中毒和程序并发症以及免疫系统疾病，所有这些都列在环孢素标签上。此外，我们还发现了与肝胆疾病等有关的新的潜在 AE。此外，还发现了意想不到的药物不良反应（ADR），如胆吻合口并发症和精子前向运动性降低。重要的是，这些新确定的 ADR 未在环孢素标签上提及，它们涉及损伤、中毒和程序并发症以及 SOC 水平的调查。本研究使用 FAERS 数据库的药物警戒分析来识别与环孢素相关的新的和意外的潜在 ADR，为环孢素的安全使用提供安全提示。
