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FDA Increases Warnings and Modifies Prescribing Instructions for Anemia Drug due to Serious Allergic Reactions


The U.S. Food and Drug Administration (FDA) is strengthening their existing warning that serious and potentially fatal allergic reactions can occur with the anemia drug Feraheme (ferumoxytol).

Feraheme is in a class of medicines called intravenous (IV) iron replacement products. It is used to treat iron-deficiency anemia, which is a condition in which there is an abnormally low number of oxygen-carrying red blood cells because of an insufficient amount of iron. Feraheme is given as an IV infusion by healthcare professionals in hospitals, outpatient clinics, or medical offices. It 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.

According to the official FDA Drug Safety Communication published this week, a Boxed Warning has been approved for the serious risks involved with Feraheme, which is the FDA's strongest type of warning. Additionally, they have added a new Contraindication, a strong recommendation against use of Feraheme in patients who have had an allergic reaction to any IV iron replacement product.

The FDA specified the following recommendations for healthcare professionals regarding the use of Feraheme:

  • 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.

Read the full FDA announcement here.

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