FDA Drug Safety Communication

The U.S. Food and Drug Administration (FDA) is strengthening an existing warning that serious, potentially fatal allergic reactions can occur with the anemia drug Feraheme (ferumoxytol). We have changed the prescribing instructions and approved a Boxed Warning, FDA's strongest type of warning, regarding these serious risks. Also added is a new Contraindication, a strong recommendation against use of Feraheme in patients who have had an allergic reaction to any intravenous (IV) iron replacement product. Health care professionals should follow the new recommendations in the drug label. Patients should immediately alert their health care professional or seek emergency care if they develop breathing problems, low blood pressure, lightheadedness, dizziness, swelling, a rash, or itching during or after Feraheme administration.

Feraheme is in a class of medicines called IV iron replacement products. It is used to treat iron-deficiency anemia―a condition in which there is a lower than normal number of oxygen-carrying red blood cells because of too little iron. People with anemia may feel tired or weak, and if left untreated, anemia can damage the heart, brain, and other organs. Feraheme is specifically approved for use only in adults with iron deficiency anemia in patients with chronic kidney disease. It is given as an IV infusion by health care professionals in a hospital, outpatient clinic, or medical office. Like other IV iron products, Feraheme may only be given where emergency personnel and equipment are immediately available to treat the potentially life-threatening allergic reactions that can occur with treatment.

All IV iron products carry a risk of potentially life-threatening allergic reactions. At the time of Feraheme's approval in 2009, this risk was described in the Warnings and Precautions section of the drug label. Since then, serious reactions, including deaths, have occurred despite the proper use of therapies to treat these reactions and emergency resuscitation measures. We have evaluated this risk further and have identified ways to reduce the risk of serious allergic reactions with Feraheme.

Based on our evaluation, the prescribing instructions and other label information were updated, adding a Boxed Warning that describes these serious risks and recommending that health care professionals:

• Only administer IV iron products to patients who require IV iron therapy.
• Do not administer Feraheme to patients with a history of allergic reaction to Feraheme or other IV iron products.
• Only administer diluted Feraheme as an IV infusion over a minimum of 15 minutes. Feraheme should not be given as an undiluted IV injection.
• Closely monitor patients for signs and symptoms of serious allergic reactions, including monitoring blood pressure and pulse during Feraheme administration and for at least 30 minutes following each infusion.
• Carefully consider the potential risks and benefits of Feraheme administration in elderly patients with multiple or serious medical conditions, as these patients may experience more severe reactions.
• Carefully consider the potential risks and benefits of Feraheme administration in patients with a history of multiple drug allergies. Patients with multiple drug allergies may also be at higher risk.

View the full FDA Drug Safety Communication on FDA.gov