Shield Therapeutics has announced that ACCRUFeR (ferric maltol) is now the first and only prescription oral iron therapy approved by the U.S. Food and Drug Administration for the treatment of iron deficiency in children aged 10 years and older. The product has been approved for adults with iron deficiency since 2019.

Iron deficiency affects approximately 2.4 million children in the United States, with adolescents, particularly females aged 12 to 21, at heightened risk due to menstruation and increased iron requirements during puberty. Other contributing factors include inadequate dietary iron intake, high-intensity athletic activity, obesity and rapid growth spurts.

Health experts emphasise that early diagnosis and treatment of iron deficiency in children are critical. If left unaddressed, low iron levels may result in developmental delays, learning and concentration difficulties, reduced academic performance, behavioral concerns and compromised immune function.

Common symptoms of iron deficiency in children include persistent fatigue, paleness, irritability and difficulty keeping up with school or physical activities. Physicians typically confirm the condition through blood tests and may recommend appropriate treatment based on clinical findings.

Traditional oral iron supplements are often associated with gastrointestinal side effects such as nausea, stomach discomfort and constipation, which can affect adherence. ACCRUFeR was developed with a focus on tolerability and is designed to help restore iron levels while minimising gastrointestinal side effects in pediatric patients aged 10 and above.

The expanded approval provides a new prescription treatment option for families and healthcare providers managing iron deficiency in children.