FDA Adds Boxed Warning to Iron Replacement Injection
(MedPage Today) -- The FDA approved a label change for ferric carboxymaltose injection (Injectafer) that adds a boxed warning for the risk of symptomatic hypophosphatemia. The agency recommends monitoring of phosphate levels in patients at risk...
The U.S. Food and Drug Administration (FDA) has added a boxed warning to the label of ferric carboxymaltose injection (Injectafer), highlighting the risk of symptomatic hypophosphatemia. This iron replacement therapy, approved in 2013, is used to treat iron deficiency anemia in certain patients. The FDA recommends monitoring phosphate levels in at-risk patients and those receiving repeated therapy.
Ferric carboxymaltose has been linked to hypophosphatemia, which can lead to severe health issues like osteomalacia and fractures. The FDA advises patients to report any symptoms of low phosphate levels and for providers to monitor and manage these risks.
Written by urgent.news from MedPage Today's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
