Feraheme Gets Black Box Warning Over Fatal Allergic Reactions

Federal drug regulators have determined that the anemia drug Feraheme requires the strongest possible label warning, requiring a new “black box” warning about the risk of severe and potentially fatal allergic reactions. 

In a drug safety communication issued in March 30, the FDA indicates that at least 18 deaths have been blamed on anaphylactic shock caused by Feraheme side effects. As a result, the regulatory agency is requiring the drug makers to strengthen the label warnings about the allergic reaction risks with Feraheme.

The FDA is also contraindicating the use of Feraheme for patients who have had an allergic reaction to any intravenous (IV) iron replacement products in the past.

Ferahmeme (ferumoxytol) is an Amag Pharmaceuticals drug approved in 2009 for the treatment of anemia in patients with chronic kidney disease, which belongs to a class of drugs known as IV iron replacements. It was known even during clinical trials that the drug could cause anaphylactic shock, but the FDA says the number of injuries and deaths caused the agency to reevaluate the level of risk the drug represented.

The FDA conducted an analysis of the FDA Adverse Event Reporting System database and found 79 cases of anaphylactic reactions linked to Feraheme use.

“Of the 79 cases, 18 were fatal, despite immediate medical intervention and emergency resuscitation attempts,” the FDA warns. “The 79 patients ranged in age from 19 to 96 years. Nearly half of all cases reported that the anaphylactic reactions occurred with the first dose of Feraheme.”

The FDA is warning patients to inform health care providers if they have any drug allergies or a prior history of reactions to intravenous iron products before receiving Feraheme for the first time and before each dose. In addition, the agency warns them to look out for signs of allergic reaction while receiving a Feraheme IV injection, including.

• Breathing Problems
• Low Blood Pressure
• Dizziness and Lightheadedness
• Swelling
• Rash or Itching.

Doctors are being warned about the potential risks as well. In addition, the FDA is requesting that doctors not use Feraheme for any off-label purposes. The FDA also recommends that the drug only be used when personnel and therapies for treating anaphylaxis are immediately available.