FDA approves ferric maltol for iron deficiency in children 10 years and older

Shield Therapeutics plc announced that Accrufer (ferric maltol) has received approval from the FDA for the treatment of iron deficiency in children 10 years and older.¹ According to the company, Accrufer is the first and only prescription oral iron treatment approved by the FDA for the treatment of iron deficiency for that patient population. The product was initially approved in 2019 for adults with iron deficiency.²

Iron deficiency is the most common cause of anemia and occurs when there is insufficient iron available to support hemoglobin production. Hemoglobin is the oxygen-carrying protein within red blood cells. Iron deficiency anemia may present with fatigue, pallor, and dizziness. Causes include blood loss from gastrointestinal conditions, menstruation, malabsorption, and inadequate dietary intake.¹

In the United States, iron deficiency affects approximately 2.4 million children. Adolescents are at elevated risk. Up to 40% of females aged 12 to 21 years may be affected because of menstruation and increased iron requirements during puberty. Additional risk factors include limited intake of iron-rich foods, high-intensity athletic training, obesity, and rapid growth.¹

Early identification and treatment are important in pediatric populations. Untreated iron deficiency may be associated with developmental delays, difficulty with learning and concentration, reduced academic performance, behavioral concerns, and impaired immune function. Clinical signs may include fatigue, pallor, irritability, or difficulty keeping pace in school or activities. Evaluation generally includes laboratory testing to confirm iron deficiency or iron deficiency anemia.

Pediatric efficacy data

The pediatric indication was supported by findings from the FORTIS trial (NCT05126901), which evaluated the efficacy of ferric maltol in patients aged 10 to 17 years with iron deficiency. In the trial, 24 patients received age-based dosing of ferric maltol twice daily. At week 12, treatment was associated with a clinically meaningful mean increase in hemoglobin of 1.1 g/dL. This magnitude of change is described as comparable, on average, to the expected hemoglobin increase associated with one blood transfusion.

Safety considerations

According to the prescribing information, patients should not take ferric maltol if they are allergic to the product or any of its excipients, have hemochromatosis or other iron overload syndromes, or receive repeated blood transfusions. Use should be avoided during an inflammatory bowel disease flare. Clinicians should counsel patients regarding the potential risk of iron overload.

The most common adverse reactions reported with ferric maltol include flatulence, diarrhea, constipation, discolored feces, abdominal pain, nausea, vomiting, and abdominal discomfort or distension.

Oral iron supplementation remains a first-line approach for iron deficiency; however, gastrointestinal adverse effects such as stomach upset, nausea, and constipation can affect adherence in some patients. The company stated that “Accrufer was designed with tolerability in mind.” With this expanded indication, clinicians have an FDA-approved prescription oral iron option specifically labeled for children 10 years and older with iron deficiency.

References

1. Shield Therapeutics announces FDA approval of Accrufer, the first and only prescription oral iron therapy approved for children age 10 and older. News release. Shield Therapeutics. February 17, 2026. Accessed February 16, 2026. https://www.prnewswire.com/news-releases/shield-therapeutics-announces-fda-approval-of-accrufer-the-first-and-only-prescription-oral-iron-therapy-approved-for-children-age-10-and-older-302689814.html
2. FDA approves first prescription oral medicine for iron deficiency in pediatric patients ages 10 and older. News release. FDA. December 22, 2025. Accessed February 17, 2026. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-prescription-oral-medicine-iron-deficiency-pediatric-patients-ages-10-and-older