FDA Approves First Oral Medication for Iron Deficiency in Kids

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Source: MedPage Today

Original: https://www.medpagetoday.com/pediatrics/generalpediatrics/119163...

Published: Tue, 23 Dec 2025 12:02:34 -0500

The FDA approved Accrufer (ferric maltol) capsules as the first oral prescription medication for the treatment of iron deficiency in children 10 years of age and older.1 The drug was originally approved in 2019 for adults with iron deficiency.[Iron deficiency is the most common cause of anemia,[1] and occurs when there is not enough iron in the blood, which prevents the body from making enough hemoglobin to transport oxygen.The drug's efficacy in patients ages 10-17 years was assessed in the FORTIS study (NCT05126901) with 24 patients receiving age-appropriate doses twice daily.[The study showed a mean increase in hemoglobin of 1.1 g/dL after 12 weeks, equivalent to the effect of a single blood transfusion.The drug should not be taken by patients allergic to its components, with hemochromatosis, other iron overload syndromes, or repeated blood transfusions; it should also be avoided in the acute phase of inflammatory bowel disease.[1] The most common side effects include flatulence, diarrhea, constipation, stool discoloration, abdominal pain, nausea, vomiting, and abdominal discomfort[1].