Federal regulators have placed their most prominent safety warning on one of the most widely used intravenous iron treatments in the United States. The Food and Drug Administration approved labeling revisions for ferric carboxymaltose injection, sold as Injectafer, adding a boxed warning that describes the risk of symptomatic hypophosphatemia, meaning dangerously low levels of phosphate in the blood.
The action affects a drug that people receive in outpatient infusion suites, hematology clinics, cardiology offices, and hospital day units across the country. Injectafer is approved for iron deficiency anemia in patients one year of age and older who cannot tolerate oral iron or who do not fully respond to it, for iron deficiency in adults with non-dialysis-dependent chronic kidney disease, and for iron deficiency in adults with heart failure classified as New York Heart Association class II or III, to improve exercise capacity.
