Department of Pharmacy, Affiliated Hospital of Weifang Medical University, Weifang, China.
Ann Pharmacother. 2024 Apr;58(4):375-382. doi: 10.1177/10600280231189897. Epub 2023 Jul 31.
Drug-induced immune hemolytic anemia (DIIHA) is a rare but potentially life-threatening pharmacogenic hematological adverse effect. Updating the risk of DIIHA among the currently available drugs based on spontaneously reported adverse event data is of great significance.
This study aimed to identify the top 50 drugs associated with immune hemolytic anemia in adults as well as common drugs that could cause immune hemolytic anemia in children based on the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.
We extracted adverse events (AE) in the FAERS database from Q1 2004 to Q3 2022 using Open vigil2.1. We use the high-level term "anaemias haemolytic immune" according to the Medical Dictionary for Regulatory Activities (MedDRA) Dictionary (version 24.0). The reported correlation between drugs and DIIHA risk was identified by reported odds ratio (ROR) and proportional reporting ratio (PRR).
There were 10500309 AEs in FAERS from 2004Q1 to 2022Q3, of which 2326 (0.02%) were DIIHA cases. The incidence of DIIHA is comparable between males and females. The most common drugs associated with DIIHA in adults and children are summarized according to the number of AE reports. The top 3 categories in terms of quantity of drugs are antineoplastic agents, immunosuppressants, and antibiotics for systemic use. The top 5 drugs in terms of ROR and PRR are alemtuzumab, daclizumab, fludarabine, busulfan, and bendamustine in adults, with entecavir, treosulfan, vinorelbine, pegademase, and alemtuzumab for children.
Our study identified the most common drugs that could induce DIIHA in adults and children, as well as the respective ROR and PRR value to discover new drug signals. This study provides references to clinicians for the management of rare DIIHA.
药物诱导免疫性溶血性贫血（DIIHA）是一种罕见但潜在危及生命的药物相关血液学不良事件。基于自发报告的不良事件数据，更新目前可用药物中 DIIHA 的风险具有重要意义。
本研究旨在根据美国食品药品监督管理局不良事件报告系统（FAERS）数据库，确定与成人免疫性溶血性贫血相关的前 50 种药物，以及可能导致儿童免疫性溶血性贫血的常见药物。
我们使用 Open vigil2.1 从 2004 年第一季度到 2022 年第三季度从 FAERS 数据库中提取不良事件（AE）。我们根据监管活动医学词典（MedDRA）词典（版本 24.0）中的高级术语“anaemias haemolytic immune”来提取 AE。通过报告比值比（ROR）和比例报告比值（PRR）来确定药物与 DIIHA 风险之间的报告相关性。
从 2004 年第一季度到 2022 年第三季度，FAERS 中有 10500309 份 AE，其中 2326（0.02%）为 DIIHA 病例。DIIHA 在男性和女性中的发病率相当。根据 AE 报告数量，总结了与成人和儿童 DIIHA 相关的最常见药物。按药物数量分类，前 3 类为抗肿瘤药、免疫抑制剂和全身用抗生素。成人中 ROR 和 PRR 最高的 5 种药物为阿仑单抗、达珠单抗、氟达拉滨、白消安和苯达莫司汀，儿童中为恩替卡韦、替莫唑胺、长春瑞滨、聚乙二醇化尿酸酶和阿仑单抗。
本研究确定了成人和儿童中最常见的可引起 DIIHA 的药物，以及各自的 ROR 和 PRR 值，以发现新的药物信号。本研究为临床医生管理罕见的 DIIHA 提供了参考。
