Background

Parenteral iron is generally considered safe in adults, and severe adverse events are extremely rare. Ferric carboxymaltose (FCM), a third-generation parenteral iron product, is not licensed for pediatric use.

Objective

The aim of this study was to present our data on the safety of FCM in children with iron deficiency (ID) and/or iron deficiency anemia (IDA) and to investigate through a systematic literature review articles reporting on the safety of FCM use in children with ID/IDA.

Patients and Methods

Safety data regarding children treated with FCM for ID/IDA from four pediatric departments in Greece over a 26-month period are presented. Additionally, a literature search was performed in PubMed, Scopus, and Google Scholar on December 4, 2021 for articles reporting on the use of FCM in children with ID/IDA. Review articles, guidelines, case reports/case series, and reports on the use of FCM for conditions other than ID/IDA were excluded. Identified articles were screened for all reported adverse events (AE) that were graded according to the Common Terminology Criteria for Adverse Events, version 5.0.

Results

In our cohort, 37 children with ID/IDA received 41 FCM infusions. All infusions were tolerated well. In addition, 11 articles reporting 1231 infusions of FCM in 866 children were identified in the literature. Among them, 52 (6%) children developed AE that were graded as mild or moderate (grades I–III).

Conclusions

Our patient cohort and this literature review provide further evidence for the good safety profile of FCM in children, although well-designed prospective clinical trials with appropriate safety endpoints are still required.

中文翻译：

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儿童羧麦芽糖铁的安全性：希腊病例系列报告及文献复习

背景

肠外铁通常被认为对成人是安全的，严重的不良事件极为罕见。羧基麦芽糖铁 (FCM) 是一种第三代肠外铁产品，未获准用于儿科。

客观的

本研究的目的是展示我们关于 FCM 在缺铁 (ID) 和/或缺铁性贫血 (IDA) 儿童中的安全性的数据，并通过系统文献综述文章调查报告儿童使用 FCM 的安全性带有 ID/IDA。

患者和方法

提供了希腊四个儿科部门在 26 个月期间接受 FCM 治疗 ID/IDA 的儿童的安全数据。此外，我们于 2021 年 12 月 4 日在 PubMed、Scopus 和 Google Scholar 中进行了文献检索，以查找有关在 ID/IDA 儿童中使用 FCM 的文章。不包括评论文章、指南、病例报告/病例系列以及关于使用 FCM 治疗 ID/IDA 以外的其他疾病的报告。根据不良事件通用术语标准 5.0 版对所有报告的不良事件 (AE) 筛选已识别的文章。

结果

在我们的队列中，37 名 ID/IDA 儿童接受了 41 次 FCM 输注。所有输注均耐受良好。此外，文献中确定了 11 篇报道 866 名儿童输注 1231 次 FCM 的文章。其中，52 名（6%）儿童发展为轻度或中度（I-III 级）的 AE。

结论

我们的患者队列和这篇文献综述为 FCM 在儿童中的良好安全性提供了进一步的证据，尽管仍然需要精心设计的具有适当安全终点的前瞻性临床试验。