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FDA approves “Black Box” warning on Feraheme (ferumoxytol) because of serious, potentially fatal allergic reactions

The intravenous iron replacement product, Feraheme, has been linked to serious, sometimes fatal, allergic reactions in certain patients. As a result, the warnings and instructions that accompany the anemia drug Feraheme are being strengthened.   The FDA changed the prescribing instructions and approved a Boxed Warning, commonly referred to as a “Black Box” warning. The Boxed warning is the FDA’s strongest type of warning. The FDA also added a new Contraindication, a strong recommendation against using Feraheme in patients who have had an allergic reaction to any intravenous (IV) iron replacement product.

Feraheme is used to treat iron-deficiency anemia. Iron-deficiency anemia is a condition where the oxygen-carrying red blood cells are reduced because of too little iron.

The FDA’s safety alert, including a link to the FDA Drug Safety Communication, can be read at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm440479.htm

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