The Food and Drug Administration (FDA) has strengthened an existing warning regarding serious and potentially fatal allergic reactions that can occur with Feraheme (ferumoxytol; AMAG Pharmaceuticals).

Feraheme is a replacement product used to treat iron-deficiency anemia. The risk of potentially life-threatening allergic reactions was initially described in the Warnings and Precautions section of the drug in 2009. However, serious reactions, including deaths, have occurred since then.

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The FDA has approved several changes to the product label, including a new Boxed Warning, a Contraindication, and changed prescribing instructions. The Boxed Warning now describes the serious risks and recommends 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.

The Contraindication strongly recommends against the use of Feraheme in patients who have had an allergic reaction to any intravenous iron replacement product. The FDA is continuing to monitor and evaluate the risk of serious risks with all intravenous iron products.

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