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FDA Strengthens Warnings for Anemia Drug Feraheme (Ferumoxytol)

Serious, potentially fatal allergic reactions can occur

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: a strong recommendation against the use of Feraheme in patients who have had an allergic reaction to any intravenous (IV) iron replacement product.

Health care professionals should follow the new recommendations in the drug label, the agency says. Patients should immediately alert their health care professional or seek emergency care if they develop breathing problems, hypotension, lightheadedness, dizziness, swelling, a rash, or itching during or after the administration of Feraheme.

Ferumoxytol is an iron-replacement product used to treat iron-deficiency anemia. It is specifically approved for use only in adult patients with chronic kidney disease who experience iron deficiency anemia. The treatment is administered as an IV infusion by health care professionals in a hospital, outpatient clinic, or medical office. Like other IV iron products, ferumoxytol may be given only where emergency personnel and equipment are immediately available to treat the potentially life-threatening allergic reactions that can occur.

All IV iron products carry a risk of potentially life-threatening allergic reactions. At the time of Feraheme’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, according to the FDA. The agency has evaluated this risk further and has identified ways to reduce the risk of serious allergic reactions with Feraheme.

Based on the FDA’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 Feraheme to patients with a history of allergic reaction to Feraheme or to other IV iron products.
  • Administer diluted Feraheme only as an IV infusion over a minimum of 15 minutes. Feraheme should not be given as an undiluted IV injection.
  • Closely monitor patients for the signs and symptoms of serious allergic reactions, including monitoring blood pressure and pulse, during Feraheme administration and for at least 30 minutes after 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 FDA urges health care professionals to report adverse effects involving Feraheme or other IV iron products to the FDA MedWatch program.

Source: FDA; March 30, 2015.

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