FDA Approval of Accrufer for Pediatric Iron Deficiency

Regulatory Approval Overview

FDA Approval of Accrufer for Pediatric Iron Deficiency: The United States Food and Drug Administration (FDA) has approved Accrufer for treating iron deficiency in children aged 10 years and above. This marks the first prescription-grade oral iron medication authorised for this paediatric age group.

Earlier, Accrufer had approval only for adult patients since 2019. The expanded indication allows doctors to prescribe a regulated oral therapy rather than relying solely on dietary supplements.

Static GK fact: The FDA was established in 1906 under the Pure Food and Drugs Act to regulate medicines and medical products in the United States.

What Is Accrufer

Accrufer is an oral capsule containing ferric maltol, a stable iron complex designed to improve absorption. It delivers iron in a form that is better tolerated than traditional iron salts.

Ferric maltol reduces direct irritation of the gastrointestinal lining. This makes it suitable for patients who cannot tolerate conventional oral iron supplements.

Importance of Iron in Children

Iron deficiency is the leading cause of anaemia worldwide. It reduces the body’s ability to produce haemoglobin, which carries oxygen in red blood cells.

In children and adolescents, low iron levels can cause fatigue, poor concentration, delayed growth, and reduced academic performance. Adolescents face additional risk due to rapid growth and, in girls, menstrual blood loss.

Static GK Tip: Normal haemoglobin levels in adolescents typically range between 12–16 g/dL, depending on age and sex.

Clinical Evidence Supporting Approval

The FDA decision is based on the FORTIS clinical trial. The study included 24 patients aged 10–17 years diagnosed with iron deficiency.

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 benefit of a single blood transfusion.

Safety and Usage Restrictions

Accrufer is not suitable for all patients. It is contraindicated in children with iron overload disorders, such as haemochromatosis.

It is also not recommended for those undergoing repeated blood transfusions, patients with active inflammatory bowel disease, or individuals allergic to its components. Common side effects include nausea, constipation, diarrhoea, gas, and darkened stools.

Static GK fact: Iron overload conditions cause excess iron storage in organs, potentially damaging the liver and heart.

Broader Public Health Significance

The approval provides a non-invasive, home-based treatment option for older children. It reduces dependence on injectable iron therapies and hospital-based transfusions.

This move reflects growing regulatory attention to paediatric nutrition-related disorders, which often remain underdiagnosed despite long-term health consequences.

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FDA Approval of Accrufer for Pediatric Iron Deficiency: