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Getting the latest healthcare news for you
Getting the latest healthcare news for you
The FDA has added a boxed warning — its most serious label alert — to Injectafer (ferric carboxymaltose injection) over the risk of symptomatic hypophosphatemia. Despite prior label updates in 2020 and 2023, cases kept piling up, and data showed phosphate levels were being checked in fewer than 1 in 5 treatment episodes. Clinicians are now urged to monitor serum phosphate in at-risk patients and those receiving repeat therapy.
The FDA has escalated its safety warning on Injectafer (ferric carboxymaltose injection), adding a boxed warning — the agency's strongest label alert — to flag the risk of symptomatic hypophosphatemia. The IV iron replacement therapy, approved for patients aged 1 and older who can't tolerate oral iron, is also used in adults with chronic kidney disease and heart failure with iron deficiency.
The decision came after a review of adverse event reports and literature showing continued cases of low phosphate levels linked to single and multiple infusions — even after label revisions in 2020 and 2023. The FDA's Sentinel System data revealed a striking monitoring gap: phosphate levels were tested in fewer than 20% of treatment episodes. Generic versions of the drug are also required to update their labels accordingly.
By the Numbers:
Why it matters: Hypophosphatemia can cause muscle weakness, fatigue, seizures, and cardiac arrhythmias — serious but potentially preventable harms. This boxed warning is a system-wide call to action for clinicians to close a significant monitoring gap and better protect patients on this widely used therapy.
