Shield Therapeutics plc has announced a significant milestone for pediatric care: ACCRUFeR (ferric maltol) is now the first and only prescription oral iron treatment approved by the U.S. Food and Drug Administration for children aged 10 and older with iron deficiency.
The therapy has been available for adults since 2019, but this expanded approval now addresses a critical unmet need in pediatric patients.
Iron deficiency affects approximately 2.4 million children in the United States. Adolescents—particularly teenage girls—face an even higher risk. Studies suggest that up to 40% of females aged 12 to 21 may experience iron deficiency due to menstruation and the increased iron demands associated with puberty.
Additional risk factors include:
Despite its prevalence, iron deficiency can sometimes go unnoticed until symptoms begin affecting a child’s daily life.
Untreated iron deficiency can have serious consequences in children and teens. Beyond fatigue, low iron levels may contribute to:
Parents may notice warning signs such as unusual tiredness, paleness, irritability, or difficulty keeping up in school or extracurricular activities. Healthcare providers can confirm iron deficiency or iron deficiency anemia through simple blood tests.
One of the biggest hurdles in treating pediatric iron deficiency has been tolerability. Traditional iron supplements are often associated with gastrointestinal side effects, including nausea, stomach upset, and constipation. These issues can make adherence especially challenging for children and teenagers.
ACCRUFeR® was developed with tolerability in mind. Unlike conventional salt-based iron supplements, ferric maltol is a stable, non-salt-based oral therapy designed to improve absorption while minimizing gastrointestinal side effects. For children aged 10 and older, it offers a new prescription option aimed at restoring iron levels more comfortably and effectively.
Marketed as ACCRUFeR® in the United States and FeRACCRU® in other regions, ferric maltol represents a differentiated approach to oral iron treatment. Its unique mechanism of absorption sets it apart from traditional iron products and has demonstrated both efficacy and tolerability across multiple clinical trials.
With this pediatric approval, Shield Therapeutics expands access to a therapy that could help address one of the most common nutritional deficiencies affecting children and adolescents.
As awareness of pediatric iron deficiency continues to grow, the availability of an FDA-approved, prescription oral option tailored for young patients may mark an important step forward in improving long-term health outcomes.