FDA Approves First Prescription Oral Iron Drug for Children Aged 10+

FDA clears first prescription oral iron medicine for children

In a significant advance for paediatric healthcare, the United States Food and Drug Administration (FDA) has approved the first prescription oral medicine to treat iron deficiency in children aged 10 years and above . The decision expands therapeutic options beyond dietary supplements and injectable treatments, addressing a widespread but often underdiagnosed nutritional disorder among school-age children and adolescents.

What the approval includes

The FDA has extended approval for Accrufer , an oral capsule containing ferric maltol , for use in paediatric patients aged 10 and older diagnosed with iron deficiency. The drug was earlier authorised only for adults in 2019. With this move, doctors can now prescribe a regulated, prescription-grade oral therapy when nutritional counselling or over-the-counter supplements are insufficient.

Why iron deficiency is a concern in children

Iron deficiency is the leading cause of anaemia globally . In children and adolescents, inadequate iron levels can impair haemoglobin production, reducing oxygen delivery in the body. This often results in fatigue, poor concentration, delayed growth, weakened immunity, and lower academic performance. Risk factors include inadequate diet, poor absorption, chronic blood loss, and heavy menstrual bleeding in adolescent girls.

Evidence behind the FDA decision

The approval is based on the FORTIS clinical trial , which studied 24 patients aged 10–17 years. Participants received Accrufer twice daily for 12 weeks. Results showed an average haemoglobin increase of 1.1 g/dL , considered clinically meaningful and comparable to the effect of a blood transfusion—without injections or hospitalisation.

Safety profile and limitations

Accrufer is not recommended for children with iron overload disorders such as haemochromatosis, those undergoing repeated blood transfusions, patients with active inflammatory bowel disease, or individuals allergic to its components. Common side effects include nausea, constipation or diarrhoea, abdominal discomfort, gas, and dark stools.

Why the approval matters

The decision offers families a convenient, non-invasive, home-based treatment option and reduces dependence on injections or transfusions. It also reflects growing regulatory attention to paediatric nutrition-related disorders with long-term developmental impact.

Important Facts for Exams

• Accrufer contains ferric maltol

• Approved for children aged 10 years and above

• Iron deficiency is the most common cause of anaemia worldwide

• Approval based on the FORTIS clinical trial