Reported Severe Hypersensitivity Reactions after Intravenous Iron Administration in the European Economic Area (EEA) Before and After Implementation of Risk Minimization Measures
Reported Severe Hypersensitivity Reactions after Intravenous Iron Administration in the European Economic Area (EEA) Before and After Implementation of Risk Minimization Measures
复制标题
DOI：
10.1007/s40264-019-00868-5
复制
发表时间：
2019-10-03
期刊：
影响因子：
4.2
通讯作者：
Wohlfeil, Stefan
中科院分区：
文献类型：
--
作者：
Nathell, Lennart;Gohlke, Annegret;Wohlfeil, Stefan
简介 过敏反应等严重超敏反应 (HSR) 由于其潜在的危及生命的可能性而备受临床关注。静脉补铁产品引起的不良事件包括 HSR。欧洲药品管理局于 2013 年底进行的一项调查导致实施了风险最小化措施 (RMM)。目的 本研究评估了实施前后 4 年期间报告的与静脉铁物质暴露相关的严重 HSR 数量。方法这是一项采用病例群体设计的回顾性药物流行病学研究。我们使用监管活动医学词典首选术语“过敏反应/休克”和“类过敏反应/休克”从安全监测数据库 EudraVigilance 获取有关自发报告的严重 HSR 的信息。使用欧洲经济区国家的 IQVIA MIDAS 销售数据估算暴露程度。结果 各个产品的报告率存在差异，RMM 的实施似乎没有明显的影响。在整个研究期间，蔗糖铁 (0.03-0.20) 和葡萄糖酸铁 (0.02-0.14) 的报告率仍然较低，羧基麦芽糖铁 (1.47-0.18) 在研究开始时较高，在研究结束时较低。右旋糖酐铁（范围 0.22-2.80）和异麦芽糖苷铁（III）1000（范围 0-7.94）没有检测到明显的趋势。结论 需要未来的研究来调查与这些静脉注射铁剂产品相关的严重 HSR 报告率的巨大差异是否是由于这些物质的安全性特征的潜在差异所致。
Introduction Severe hypersensitivity reactions (HSRs) such as anaphylaxis are of great clinical concern because of their life-threatening potential. The adverse events attributable to intravenous iron products include HSRs. An investigation by the European Medicines Agency presented in late 2013 resulted in the implementation of risk minimization measures (RMMs). Objective This study evaluated the number of severe HSRs reported for intravenous iron substances related to exposure for the 4-year periods before and after this implementation. Methods This was a retrospective pharmacoepidemiologic study with a case-population design. We obtained information from the safety surveillance database EudraVigilance on spontaneously reported severe HSRs using the Medical Dictionary for Regulatory Activities preferred terms "anaphylactic reaction/shock" and "anaphylactoid reaction/shock". Exposure was estimated using IQVIA MIDAS sales data in European economic area countries. Results Reporting rates for individual products were heterogenous, and the implementation of RMMs appeared to have no clear impact. Reporting rates remained low for the full study period for iron sucrose (0.03-0.20) and ferric gluconate (0.02-0.14) and were higher at the beginning and lower at the end of the study period for ferric carboxymaltose (1.47-0.18). No clear trend was detected for iron dextran (range 0.22-2.80) and iron (III) isomaltoside 1000 (range 0-7.94). Conclusions Future research is needed to investigate whether the wide variability in reporting rates for severe HSRs associated with these intravenous iron products are due to potential differences in the safety profiles of these substances.