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News From the Food and Drug Administration
May 5, 2015

Black Box Warning for Anemia Drug

JAMA. 2015;313(17):1704. doi:10.1001/jama.2015.4114

The drug Feraheme should not be given to patients who have had an allergic reaction to any intravenous iron replacement product, according to a new contraindication added to its label.

In addition to requiring the new contraindication, the Food and Drug Administration (FDA) also strengthened an existing warning that serious, potentially fatal allergic reactions have occurred in patients using Feraheme. It is now a black box warning, the strongest type.

Feraheme, the brand name for ferumoxytol, is approved only for patients with chronic kidney disease who have iron deficiency anemia. Signs of an allergic reaction include breathing problems, low blood pressure, dizziness, rash, or itching during or after Feraheme administration, according to an FDA drug safety communication (http://1.usa.gov/1P129oK).