In pediatric patients with iron-deficiency anemia (IDA), a new study has suggested that intravenous (IV) therapy with ferric carboxymaltose is both effective and safe. Results of the study were presented at the 2021 American Society of Pediatric Hematology/Oncology (ASPHO) meeting by Chandni Dargan, MD, of Children’s Mercy Hospital in Kansas City, Missouri, and colleagues.

For adult patients with IDA, ferric carboxymaltose was approved in 2013 by the US Food and Drug Administration as an IV treatment option. However, it has not been approved for use in the pediatric population. The study investigators compared the use of various IV iron formulations at a large pediatric hospital, in addition to comparing the efficacy and safety of 3 IV iron formulations.

The study was a single-center, retrospective chart review of pediatric patients treated with iron dextran, iron sucrose, and/or ferric carboxymaltose from April 1, 2016, to June 30, 2020. Patient demographics, information regarding iron administration, and laboratory values prior to and following iron infusion were evaluated.

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IV iron was mostly given as iron sucrose in 64.3% of cases in 2016, while iron dextran was used for the other 35.7% of cases. During the study years, however, there was a shift toward more use of ferric carboxymaltose and less use of iron dextran. In the early half of 2020, iron dextran was not used in any cases, but ferric carboxymaltose was given in more than half (53.4%) of IV iron administrations.

Achievement of target hemoglobin and/or ferritin levels was reached with 1 to 2 doses of ferric carboxymaltose in approximately 88% of patients receiving this formulation. This was compared with the efficacy of IV iron sucrose, with which slightly fewer than half (49%) of the patients were able to reach target hemoglobin and/or ferritin levels after more than 2 doses.

The change in hemoglobin levels from baseline to 60 days following the first iron infusion was 2.05 g/dL with ferric carboxymaltose and 1.5 g/dL with iron sucrose (P =.024).

Among 164 evaluable infusions of ferric carboxymaltose, 7 adverse events were reported. A total of 610 iron sucrose infusions were evaluated for safety, with 10 adverse events reported.

The study investigators concluded that it was becoming more common to use IV ferric carboxymaltose at their center and that this treatment was both efficacious and tolerable in treating iron-deficiency anemia.

“However, further prospective studies analyzing the efficacy of ferric carboxymaltose with more consistent and standardized lab follow-up, and standardized adverse event documentation, would be beneficial,” Dr Dargan advised in an audio recording accompanying the poster.


Dargan C, Simon D, Noel-MacDonnell J, Sharma M. A study examining the safety and efficacy of ferric carboxymaltose in a large pediatric cohort. Poster presented at: 2021 American Society of Pediatric Hematology/Oncology meeting; April 21-23, 2021; virtual.