FDA Strengthens Warning and Prescribing Instructions for Feraheme

Feraheme (ferumoxytol), an IV iron replacement product, is prescribed to treat iron-deficiency anemia; a condition in which the body lacks the proper amount of oxygen-carrying red blood cells because of too little iron. Feraheme is used in treating adults with anemia who also have chronic kidney disease. The FDA has strengthened the warning for Feraheme regarding the potentially fatal allergic reactions that occur. The prescribing instructions have been changed and a Boxed Warning, the FDA's strongest, has been added. Also added was a recommendation against use of Feraheme in patients who have had an allergic reaction to any intravenous (IV) iron replacement product.

Iron IV products all carry a risk of life-threatening allergic reactions. Upon approval of Feraheme's in 2009, the potential allergic reaction was described in the Warnings and Precautions section of the drug label. Since 2009, serious reactions, including death, have occurred in patients using Feraheme despite the proper treatment and emergency resuscitation measures. The FDA will continue to monitor and evaluate the danger of allergic reactions with all IV iron products.

The updated warnings include:

  • 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.

Healthcare professionals and patients should 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:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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