Government and Regulations

FDA strengthens allergy warning for IV anemia therapy ferumoxytol



The warning about potentially life-threatening allergic reactions with the intravenous anemia drug ferumoxytol is being strengthened to reflect cases of allergic reactions, including fatalities, associated with this drug since approval, the Food and Drug Administration announced on March 30.

Information about the risk of potentially life-threatening allergic reactions was included in the warnings and precautions section of the prescribing information for ferumoxytol (Feraheme) when it was approved in 2009, and this risk is associated with all IV iron therapies. Since approval of ferumoxytol, however, “serious reactions, including deaths, have occurred despite the proper use of therapies to treat these reactions and emergency resuscitation measures,” according to the FDA’s statement, a drug safety communication.

Ways to reduce this risk have been identified and “health care professionals should follow the new recommendations in the drug label,” which includes the new contraindication, a “strong recommendation against use of Feraheme in patients who have had an allergic reaction to any intravenous (IV) iron replacement product,” the statement said.

Other recommendations included in the revised prescribing information include instructions to administer diluted ferumoxytol in an IV infusion administered over at least 15 minutes and to never administer it as an undiluted solution; to closely monitor patients for signs and symptoms of serious allergic reactions, which includes monitoring pulse and blood pressure during administration and for at least 30 minutes after each infusion; and to “carefully consider the potential risks and benefits” of the drug in elderly patients and in patients who have multiple drug allergies, two groups of patients who may be at increased risk for serious reactions.

Between June 2009 and June 30, 2014, 79 reports of anaphylactic reactions associated with ferumoxytol were identified in people from aged 19-96 years in the FDA Adverse Event Reporting System database, of which 18 were fatal, “despite immediate medical intervention and emergency resuscitation attempts. Almost half were reported with the first dose and 60 cases – about 75% – were reported to have started during the infusion or within 5 minutes after it had been fully infused.

Of the 79 cases, 34 (43%) were reported in people with a history of drug allergy; and 24% had a history of multiple drug allergies. Cardiac arrest, hypotension, dyspnea, nausea, vomiting, and flushing were among the common symptoms described.

Serious adverse events associated with ferumoxytol or other IV iron therapies should be reported to the FDA’s MedWatch program at 800-332-1099 or on-line at

Next Article:

   Comments ()