OBJECTIVES: Intravenous (IV) iron preparations rapidly correct iron deficiency anemia. Rare but potentially life-threatening hypersensitivity reactions can occur during IV iron administration. We examined the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database to explore and compare real-world adverse events (AEs) associated with different IV iron preparations and their direct medical costs.

METHODS: Cases of hypersensitivity reactions and anaphylaxis/anaphylactic shock (using MedDRA terms) associated with IV iron preparations in the USA and submitted to FAERS (January 1, 2014 to June 30, 2019) were extracted and cleaned using Evidex by Advera Health. Proportions of cases with AE-related hospitalization/death were calculated. The association strength between each preparation and AE was calculated using the Reporting Odds Ratio lower bound 90% confidence interval (ROR05); values >1 indicating a signal and ≥2 a strong signal. Medical costs associated with the AEs were estimated using Agency for Healthcare Research and Quality/Healthcare Cost and Utilization Project 2016 data.

RESULTS: Ferumoxytol and iron dextran had the highest ROR05 for hypersensitivity reactions (both 2.39) and greatest proportion of associated hospitalizations (both 33.3%) and deaths (8.5% and 5.9%, respectively), followed by iron sucrose (ROR05 1.65, hospitalizations 21.6%, deaths 3%), and ferric carboxymaltose (ROR05 1.51, hospitalizations 7.2%, no deaths). For anaphylaxis/anaphylactic shock, ROR05/hospitalizations/deaths were 10.50/42.4%/11.9% with ferumoxytol, 7.83/50.0%/5.6% with iron dextran, 2.96/38.7%/6.5% with iron sucrose, and 2.18/11.4%/no deaths with ferric carboxymaltose. Mean costs associated with these AEs per total patients exposed were highest for ferumoxytol ($1.13), then iron dextran ($0.65), ferric carboxymaltose ($0.50), and iron sucrose ($0.15).

CONCLUSIONS: This real-world analysis of FAERS data suggests that, among patients treated with an IV iron preparation, anaphylaxis and hypersensitivity reaction risk is highest with ferumoxytol and lowest with ferric carboxymaltose. Mean cost associated with these AEs per total patients exposed was highest for ferumoxytol and lowest for iron sucrose.