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FDA Strengthens Warnings and Changes Prescribing Instructions for Anemia Drug Feraheme (Ferumoxytol)

Agency cites risk of serious allergic reactions

The FDA is strengthening an existing warning that serious, potentially fatal allergic reactions can occur with the anemia drug Feraheme (ferumoxytol, Amag Pharmaceuticals). The agency has changed the prescribing instructions and has approved a boxed warning regarding these serious risks. Also added is a new contraindication against the use of ferumoxytol in patients who have had an allergic reaction to any intravenous (IV) iron-replacement product.

Ferumoxytol is used to treat iron-deficiency anemia. People with anemia may feel tired or weak, and if left untreated, the disease can damage the heart, brain, and other organs. Ferumoxytol is approved for use only in adults with iron-deficiency anemia and chronic kidney disease. It is given as an IV infusion by health care professionals in a hospital, outpatient clinic, or medical office.

Like other IV iron products, ferumoxytol may be administered only where emergency personnel and equipment are immediately available to treat the potentially life-threatening allergic reactions that can occur with treatment.

At the time of the product’s 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 evaluated this risk further and has identified ways to reduce the risk of serious allergic reactions with ferumoxytol.

Based on the agency’s evaluation, the prescribing instructions and other label information were updated, adding a boxed warning that describes these serious risks and recommending that health care professionals:

  • Administer IV iron products only to patients who require IV iron therapy.
  • Do not administer ferumoxytol to patients with a history of allergic reaction to ferumoxytol or other IV iron products.
  • Administer diluted ferumoxytol only as an IV infusion over a minimum of 15 minutes. Ferumoxytol 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 ferumoxytol administration and for at least 30 minutes after each infusion.
  • Carefully consider the potential risks and benefits of ferumoxytol 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 ferumoxytol administration in patients with a history of multiple drug allergies. Patients with multiple drug allergies may also be at higher risk.

The FDA is continuing to monitor and evaluate the risk of serious allergic reactions with all IV iron products. The agency urges health care professionals to report adverse events involving ferumoxytol or other IV iron products to the FDA MedWatch program.

Source: FDA; April 30, 2015.

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