Stronger warnings were added to the safety label of the anemia drug Feraheme (ferumoxytol) regarding serious and potentially deadly allergic reactions, the Food and Drug Administration (FDA) announced. Prescribing instructions have also been changed and a new Contraindication has been added warning against use of the drug in patients who have had an allergic reaction to any intravenous (IV) iron replacement product.
All IV iron products can cause potentially life threatening allergic reactions. When Feraheme was approved in 2009, this risk was described in the Warnings and Precautions section of the drug’s label. Since then, serious reactions, including deaths, have occurred despite proper use of therapies to treat these reactions, and emergency resuscitation measures. The FDA evaluated this risk and has identified ways to reduce the risk of serious allergic reactions with Feraheme.
The agency will continue to monitor and evaluate the risk of serious reactions with all IV iron products, and will update the public as new information comes available.
Feraheme is in a class of medications called IV iron replacement products. It is used to treat iron-deficiency anemia, a condition in which there is a lower than normal 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.
Based on the FDA’s evaluation, a new black box warning and prescribing changes were added that describes these serious risks, and offers recommendations to health care providers that includes monitoring patients for signs and symptoms of allergic reactions, especially elderly patients and those with multiple or serious medical conditions as they may experience more severe reactions.
Health care professionals and patients are encouraged to report any adverse events or side effects to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.