FDA Expands Accrufer Approval to Pediatric Iron Deficiency

Key facts

• The Food and Drug Administration has expanded the approval of Accrufer® (ferric maltol) to include treatment of pediatric patients aged 10 years and older with iron deficiency.
• Findings from the FORTIS trial showed the mean change in hemoglobin at week 12 was 1.10 g/dL.
• Among the patients who received the recommended dosage of 30 mg twice daily (n=21), the mean change in Hb at week 12 was 1.23 g/dL (SD: 1.00).
• At baseline, the mean ferritin level of study participants was 11.4 mcg/L; following treatment with Accrufer, the mean ferritin level at week 12 was 20 mcg/L (mean overall improvement of 8.6 mcg/L).
• The most common adverse reactions reported with Accrufer include flatulence, diarrhea, constipation, discolored feces, abdominal pain, nausea, vomiting, and abdominal discomfort/distention.