FDA Orders Stricter Warnings for Ferumoxytol (Feraheme )

Alicia Ault


March 30, 2015

The US Food and Drug Administration (FDA) is ordering stricter warnings and contraindications for the anemia drug ferumoxytol (Feraheme, AMAG Pharmaceuticals), stating that even with current warnings, there have been 79 anaphylactic reactions resulting in 18 deaths since the drug was approved in 2009.

Ferumoxytol has carried the same warning as other intravenous iron-replacement products, that it could cause potentially life-threatening allergic reactions. The drug — approved for use only in adults with chronic kidney disease who have iron-deficiency anemia — has been contraindicated also in patients with known hypersensitivity to ferumoxytol or any of its components or a history of allergic reaction to any intravenous iron product.

Even so, the FDA found 79 anaphylactic reactions in its Adverse Event Reporting System between June 2009 and June 30, 2014. The patients were aged 19 to 96 years. Half of the reactions occurred with the first dose, and three-quarters began during infusion or within 5 minutes of completion. Eighteen of the 79 patients died despite immediate medical intervention and emergency resuscitation attempts, the FDA said in a news release.

Thirty-four of the 79 patients had a medical history of drug allergy, and 19 patients had a history of multiple drug allergies.

The agency is now requiring a boxed warning — it strongest — with new cautions and has asked AMAG Pharmaceuticals to add a new contraindication of a strong recommendation against use in patients who have had an allergic reaction to any intravenous (IV) iron-replacement product.

The FDA said that patients should immediately alert their clinicians or seek emergency care if they develop breathing problems, low blood pressure, lightheadedness, dizziness, swelling, a rash, or itching during or after ferumoxytol administration.

Potential adverse events can be reduced, the agency said, if healthcare professionals:

* Administer IV iron products only to patients who require IV iron therapy

* Not administer ferumoxytol to patients with a history of allergic reaction to ferumoxytol or other IV iron products

* Only administer diluted ferumoxytol as an IV infusion over a minimum of 15 minutes, and not give it as an undiluted IV injection

* Closely monitor patients for signs and symptoms of serious allergic reactions, including monitoring blood pressure and pulse during administration and for at least 30 minutes following each infusion

* Carefully consider the risks and benefits in elderly patients with multiple or serious medical conditions, and in patients with a history of multiple drug allergies

The FDA said that it is continuing to monitor and evaluate the risk for serious allergic reactions with all IV iron products, and it urged physicians and patients to continue to report side effects involving ferumoxytol or other IV iron products.


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