Accrufer: FDA Expands Use of Oral Iron Treatment for Kids Ages 10 and Older

Accrufer (ferric maltol) is an oral capsule approved by the FDA to treat iron deficiency in kids ages 10 years and older. It helps your body absorb iron through your digestive system, which is important for making healthy red blood cells. Without enough iron, your body cannot produce enough red blood cells, which can lead to anemia. This can make you feel tired or dizzy, or make you look pale. Low iron can be caused by blood loss from stomach or intestinal problems, heavy periods, trouble absorbing iron from food, or not getting enough iron in your diet.

Iron deficiency is the most common cause of anemia and affects about 20 million people in the U.S. Until now, no FDA-approved oral iron treatments were available specifically for children in this age group. This approval gives families and health care providers a new option that doesn’t involve getting iron through an injection or intravenous (IV) line. Accrufer was first approved in 2019 for adults with iron deficiency.

Why Was It Approved?

The FDA approved Accrufer for kids ages 10 and older after a study showed it helped increase the level of hemoglobin, which is necessary for carrying oxygen in your blood.

In the trial, 24 patients (ages 10-17 years) took Accrufer twice daily at doses based on their age. After 12 weeks, people in the study had an average increase in hemoglobin of 1.1 g/dL, which is roughly the same improvement expected from one blood transfusion.

The most common side effects were related to the stomach, such as gas, diarrhea, constipation, and nausea. These side effects were similar to what adults had in earlier studies. No serious side effects were reported in children.

What Do I Need to Know?

You take Accrufer as a capsule twice a day on an empty stomach – either one hour before or two hours after eating. Be sure to swallow the capsule whole. Don’t open, crush, or chew it.

You shouldn’t take Accrufer if you have too much iron in your body, are getting regular blood transfusions, or are having a flare-up of inflammatory bowel disease (a long-lasting condition that causes swelling and irritation in the intestines).

Accrufer can also affect how other medicines work, so your health care provider may ask you to take it at a different time than your other pills. Also, tell them about all prescription medicines, over-the-counter products, herbal remedies, and supplements that you take.

Talk to your health care provider if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.