The Food and Drug Administration (FDA) is strengthening the existing warning about serious, potentially fatal allergic reactions that can occur with the anemia drug Feraheme (ferumoxytol).
The agency FDA changed the prescribing instructions and approved a Boxed Warning—the FDA’s strongest type of warning. The FDA also added 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.
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. Feraheme is specifically approved for use only in adults with iron deficiency anemia in patients with chronic kidney disease, according to the FDA.
All IV iron products carry a risk of potentially life-threatening allergic reactions, the agency explains. When Feraheme received FDA 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.
The FDA has further evaluated this risk and has identified ways to reduce the risk
The FDA has further evaluated this risk and has identified ways to reduce the risk of serious allergic reactions. The FDA said it is continuing to monitor and evaluate the risk of serious allergic reactions with all IV iron products and will update the public as new information becomes available.
The FDA advises any patient receiving Feraheme to immediately notify a health care professional or seek emergency care if any of the following signs and symptoms develop during and after Feraheme administration:
- Breathing problems
- Low blood pressure
- Dizziness or lightheadedness, which are symptoms of low blood pressure
- Rash or itching
Based on FDA’s evaluation, the Feraheme prescribing instructions and other label information were updated. A Boxed Warning was added to describe these serious risks. The warning recommends that health care professionals:
- Administer IV iron products only 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.
- 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; 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.
The FDA encourages health care professionals and patients to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/MedWatch/report.