Anemia Drug Feraheme Allergic Reactions. The Food and Drug Administration (FDA) is strengthening the existing warning about serious, potentially fatal allergic reactions that can occur with the anemia drug Feraheme (ferumoxytol). The agency FDA changed the prescribing instructions and approved a Boxed Warning—the FDA’s strongest type of warning. The FDA also added a new contraindication, a […]
Anemia Drug Feraheme Allergic Reactions. The Food and Drug Administration (FDA) is strengthening the existing warning about serious, potentially fatal allergic reactions that can occur with the anemia drug Feraheme (ferumoxytol). The agency FDA changed the prescribing instructions and approved a Boxed Warning—the FDA’s strongest type of warning. The FDA also added a new contraindication, a strong recommendation against use of Feraheme in patients who have had an allergic reaction to any intravenous (IV) iron replacement product.
Feraheme is in a class of medicines called IV iron replacement products. It is used to treat iron-deficiency anemia―a condition in which there is a lower than normal number of oxygen-carrying red blood cells because of too little iron. Feraheme is specifically approved for use only in adults with iron deficiency anemia in patients with chronic kidney disease, according to the FDA.
All IV iron products carry a risk of potentially life-threatening allergic reactions, the agency explains. When Feraheme received FDA 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.
The FDA has further evaluated this risk and has identified ways to reduce the risk of serious allergic reactions. The FDA said it is continuing to monitor and evaluate the risk of serious allergic reactions with all IV iron products and will update the public as new information becomes available.
The FDA advises any patient receiving Feraheme to immediately notify a health care professional or seek emergency care if any of the following signs and symptoms develop during and after Feraheme administration:
Based on FDA’s evaluation, the Feraheme prescribing instructions and other label information were updated. A Boxed Warning was added to describe these serious risks. The warning recommends that health care professionals:
The FDA encourages health care professionals and patients 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: www.fda.gov/MedWatch/report.
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