Pharmacoepidemiology and Risk Management, RTI Health Solutions, Barcelona, Spain.
Department of Internal Medicine-QiN-group, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.
Pharmacoepidemiol Drug Saf. 2021 Oct;30(10):1447-1457. doi: 10.1002/pds.5319. Epub 2021 Jul 12.
This post-authorisation safety study estimated the risk of anaphylaxis in patients receiving intravenous (IV) iron in Europe, with interest in iron dextran and iron non-dextrans. Studies conducted in the United States have reported risk of anaphylaxis to IV iron ranging from 2.0 to 6.8 per 10 000 first treatments.
Cohort study of IV iron new users, captured mostly through pharmacy ambulatory dispensing, from populations covered by health and administrative data sources in five European countries from 1999 to 2017. Anaphylaxis events were identified through an algorithm that used parenteral penicillin as a positive control.
A total of 304 210 patients with a first IV iron treatment (6367 iron dextran), among whom 13-16 anaphylaxis cases were identified and reported as a range to comply with data protection regulations. The pooled unadjusted incidence proportion (IP) ranged from 0.4 (95% confidence interval [CI], 0.2-0.9) to 0.5 (95% CI, 0.3-1.0) per 10 000 first treatments. No events were identified at first dextran treatments. There were 231 294 first penicillin treatments with 30 potential cases of anaphylaxis (IP = 1.2; 95% CI, 0.8-1.7 per 10 000 treatments).
We found an IP of anaphylaxis from 0.4 to 0.5 per 10 000 first IV iron treatments. The study captured only a fraction of IV iron treatments administered in hospitals, where most first treatments are likely to happen. Due to this limitation, the study could not exclude a differential risk of anaphylaxis between iron dextran and iron non-dextrans. The IP of anaphylaxis in users of penicillin was consistent with incidences reported in the literature.
本项上市后安全性研究旨在评估欧洲接受静脉铁（IV 铁）治疗的患者发生过敏反应的风险，重点关注铁右旋糖酐和非右旋糖酐铁。美国开展的研究报告称，首次 IV 铁治疗发生过敏反应的风险为每 10000 例治疗 2.0 至 6.8 例。
本研究为 IV 铁新使用者的队列研究，数据主要来源于五个欧洲国家的医疗和行政数据源中记录的药房门诊配药记录。通过一种算法识别过敏反应事件，该算法将注射用青霉素作为阳性对照。
共纳入 304210 例首次 IV 铁治疗（6367 例铁右旋糖酐）的患者，其中确定并报告了 13-16 例过敏反应病例，该范围的报告是为了遵守数据保护法规。未调整的总发生率（IP）范围为每 10000 例首次治疗 0.4（95%置信区间[CI]，0.2-0.9）至 0.5（95% CI，0.3-1.0）。首次铁右旋糖酐治疗未发生过敏反应事件。首次青霉素治疗 231294 例，潜在过敏反应病例 30 例（发生率 IP 为 1.2；95% CI，每 10000 例治疗 0.8-1.7）。
我们发现首次 IV 铁治疗的过敏反应发生率为每 10000 例 0.4 至 0.5。本研究仅捕获了在医院进行的 IV 铁治疗的一小部分，而大多数首次治疗很可能发生在医院。由于这一局限性，该研究不能排除铁右旋糖酐和非右旋糖酐铁之间过敏反应风险的差异。青霉素使用者发生过敏反应的发生率与文献报道的发生率一致。
