A systematic literature review and meta-analysis of the incidence of serious or severe hypersensitivity reactions after administration of ferric derisomaltose or ferric carboxymaltose

source extracted confidence: high 2026-04-09
#humans #incidence #prospective-studies #bayes-theorem #iron

A systematic literature review and meta-analysis of the incidence of serious or severe hypersensitivity reactions after administration of ferric derisomaltose or ferric carboxymaltose

Kennedy et al., 2023 | Int J Clin Pharm | Meta Analysis

Citation

Kennedy Nicholas A, Achebe Maureen M, ... Pollock Richard F. A systematic literature review and meta-analysis of the incidence of serious or severe hypersensitivity reactions after administration of ferric derisomaltose or ferric carboxymaltose. Int J Clin Pharm. 2023-Jun;45(3):604-612. doi:10.1007/s11096-023-01548-2

Abstract

BACKGROUND: Intravenous iron is the preferred treatment for patients with iron deficiency anemia in a variety of clinical situations. Although uncommon, administration of modern IV iron formulations can result in hypersensitivity reactions (HSRs) and, rarely, anaphylactic or anaphylactoid reactions. AIM: The objective of the present study was to systematically review the literature to identify and analyze data on the incidence of HSRs after administration of ferric derisomaltose (FDI) or ferric carboxymaltose (FCM). METHOD: A prospectively-registered systematic literature review was conducted to identify prospective randomized controlled trials comparing FDI and FCM with other intravenous iron formulations or oral iron. Searches were conducted in PubMed (including MEDLINE), EMBASE, and the Cochrane Library in November 2020. The relative incidence of serious or severe HSRs occurring on the day or day after dosing of intravenous iron, recorded under the standardized Medical Dictionary for Regulatory Activities query for anaphylactic reaction. RESULTS: Data were obtained from seven randomized controlled trials of FCM (N = 2683) and ten of FDI (N = 3474) enrolling 10,467 patients in total. The number of patients experiencing any serious or severe HSR event was 29/2683 (1.08%) with FCM versus 5/3474 with FDI (0.14%). Bayesian inference of proportions showed the event rates to be significantly lower with FDI relative to FCM. CONCLUSION: HSR events were uncommon with both intravenous iron formulations; however, the present study showed a significantly lower incidence of HSRs with FDI relative to FCM. Further large-scale, head-to-head trials of the iron formulations would be required to confirm this finding.

Key Findings

Data were obtained from seven randomized controlled trials of FCM (N = 2683) and ten of FDI (N = 3474) enrolling 10,467 patients in total. The number of patients experiencing any serious or severe HSR event was 29/2683 (1.08%) with FCM versus 5/3474 with FDI (0.14%). Bayesian inference of proportions showed the event rates to be significantly lower with FDI relative to FCM.

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population iron deficiency anemia in
Sample Size 2683
Age Range See abstract
Condition deficiency

MeSH Terms

  • Humans
  • Incidence
  • Prospective Studies
  • Bayes Theorem
  • Iron
  • Anemia, Iron-Deficiency
  • Administration, Intravenous
  • Anaphylaxis
  • Disaccharides
  • Ferric Compounds
  • Maltose

Evidence Classification

  • Level: Meta Analysis
  • Publication Types: Systematic Review, Meta-Analysis, Journal Article
  • Vertical: iron

Provenance

Source extracted via PubMed E-utilities API on 2026-04-09