Strongest FDA Warning for Anemia Drug

The anemia drug Feraheme (ferumoxytol (AMAG Pharmaceuticals, Waltham, MA) will now carry the FDA’s strongest warning. The FDA has stipulated that the drug must carry a boxed warning that states “serious, potentially fatal allergic reactions can occur with the anemia drug Feraheme (ferumoxytol).”

In a Drug Safety Communication issued on March 31, 2015, The FDA said it will continue to monitor and evaluate the risk of serious allergic reactions with all IV iron products, and will provide updates as new information becomes available. All IV iron products carry a risk of potentially life-threatening allergic reactions, the communication stated.

When Feraheme was approved 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 (more information is available at the Drug Safety Communication/Data Summary).

The data summary shows that 79 anaphylactic reactions have occurred since 2009, 18 of which were fatal. In nearly half of the 79 cases, anaphylactic reactions occurred with the first dose of Feraheme. In 75 percent of cases, the reaction began during the infusion or within 5 minutes of the administration being completed.

“Frequently reported symptoms included cardiac arrest, hypotension, dyspnea, nausea, vomiting, and flushing,” the Data Summary reported. “Of the 79 cases, 43 percent of the patients had a medical history of drug allergy, and 24 percent had a history of multiple drug allergies.”

Among the FDA’s recommendations for the drug:

  • 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 after each infusion.
  • Carefully consider the potential risks and benefits of Feraheme administration in patients with a history of multiple drug allergies. Patients with multiple drug allergies, as with older patients, may also be at higher risk.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at