Ferric Citrate Hydrate Successfully Treats Iron Deficiency Anemia, Study Finds

Results from a multicenter, open-label, uncontrolled, single-arm comparative study have indicated that ferric citrate hydrate (FCH) treatment exhibited a satisfactory medication completion rate in patients with iron deficiency anemia (IDA).

IDA is the most prevalent type of anemia in the world. Iron is critical to respiration, energy production, DNA synthesis, and cell proliferation; however, since large amounts of iron can be toxic, uptake is limited to 1-2 mg daily. Most of the body’s 25 mg of required daily iron is therefore provided through recycling broken down red blood cells. This mechanism is controlled by hepcidin.2

IDA is particularly prevalent in women, as a significant amount of iron is lost monthly during menstruation. Pregnant women with IDA can experience severe side effects, including mental health issues, impairment of the immuno-inflammatory system, premature birth, and fetal death.1

Oral supplements are generally considered first-line treatment for IDA – hemoglobin levels typically start to increase within 2 weeks of first administration, and clinicians typically advise continuous iron supplementation for a minimum of 3-6 months until serum ferritin normalization is achieved. However, many iron supplements have gastrointestinal side effects, such as nausea and vomiting.1

“No previous studies have evaluated the clinical evidence and QoL changes when switching to FCH from another oral iron preparation among patients with IDA who have experienced N/V,” wrote Osamu Wada-Hiraike, department of obstetrics and gynecology, the University of Tokyo, and colleagues. “This study evaluated the use, efficacy, and QoL changes when patients with IDA who were intolerant to their previous oral iron preparations due to N/V switched to FCH.”1

Wada-Hiraike and colleagues included data from female patients with IDA, collected from 12 sites around Japan. FCH was administered starting at baseline, with patients taking 500 mg (2 x 250 mg tablets) once daily, not to exceed 500 mg twice daily. 41 patients enrolled and 30 were included in the study – of these, 24 (80%) met the hemoglobin target (>11 g/dl) at week 4 and 6 (20%) continued treatment until week 8.1

All 30 patients were menstruating during the study; 29 patients (96.7%) exhibited abnormal uterine bleeding, most commonly caused by leiomyoma (22/30 patients; 73.3%). 22 patients (73.3%) had previous sodium ferrous citrate oral iron preparation use – time from last administration ranged from ≤3 days to >52 weeks. Frequency of oral iron preparation administration was ≥8 times in 19/30 patients, 2-7 times in 9/30 patients, once in 1/30, and unknown in 1/30.1

Of the 30 enrolled participants, 24 reached ≥11 g/dl hemoglobin by week 4 and ended treatment, while 6 continued to week 8. Medication compliance was 93.92% +/- 8.11% (mean +/- standard deviation [SD]), and completion rate was 100% (95% CI, 88.4-100%). Questionnaire findings indicated that the most severe nausea score decreased from 5.7 +/- 2.4 to 1.7 +/- 2.1 (mean +/- SD), N/V incidence decreased from 100 to 63.3%, and patients reporting that N/V did not interfere with daily life increased from 6.7 to 52.6% following the switch to FCH.1

Scores for all eight Short-Form 36-Item Health Survey v2 subscales improved, with significant increases in six. Nine ADR events occurred in six patients (20%), including nausea in 3 (10%), but none were serious or resulted in discontinuation of treatment.1

Investigators noted that FCH demonstrated improved tolerability compared with more common oral iron preparations. Lab data also indicated an overall improvement in anemia, reflected in previous phase 3 trials.1

“For patients who experienced N/V with previous oral iron preparations, switching to FCH improved multiple aspects of treatment, including medication compliance, the degree to which N/V interferes with daily life, and medication adherence through improvements in QoL,” Wada-Hiraike and colleagues wrote. “FCH is expected to be an attractive first-line treatment option that is less burdensome for patients and allows them to continue treatment, given the associated QoL improvements.”1

References

1. Wada-Hiraike O, Maruyama A, Mitobe Y, et al. A Multicenter Single-Arm Study of Switching to Ferric Citrate Hydrate for Iron Deficiency Anemia in Patients Intolerant to Oral Iron: RIO-SWITCH. Adv Ther. 2025;42(5):2150-2167. doi:10.1007/s12325-025-03123-9

2. Camaschella C. Iron-deficiency anemia. N Engl J Med. 2015;372(19):1832-1843. doi:10.1056/NEJMra1401038