September 03, 2026
1 min read
Key takeaways:
- The FDA recommends phosphate monitoring for patients at risk for hypophosphatemia or receiving repeat therapy.
- Fewer than 20% of Injectafer administration episodes had serum phosphate laboratory testing.
The FDA added a boxed warning detailing the known risk for symptomatic hypophosphatemia associated with ferric carboxymaltose injection, according to an agency press release.
The boxed warning recommends phosphate monitoring for patients at risk for hypophosphatemia and any patients who receive a repeat course of therapy within 3 months of the prior course. Generic ferric carboxymaltose injection products are also expected to update their labels to reflect the added boxed warning, according to the release.
Ferric carboxymaltose injection (Injectafer, Daiichi Sankyo/American Regent), a prescription iron replacement medicine given intravenously, is approved by the FDA for patients aged 1 year and older who cannot tolerate or do not fully respond to oral iron. It is also approved for adults with chronic kidney disease not on dialysis with iron deficiency and adults with New York Heart Association class II/III heart failure with iron deficiency to improve exercise capacity.
The decision to add the boxed warning stemmed from an assessment of multiple data sources, including the FDA Adverse Event Reporting System and literature reports. Multiple cases of symptomatic hypophosphatemia tied to single and multiple infusions of ferric carboxymaltose injection were reported despite previous labeling revisions in 2020 and 2023 emphasizing the risk, according to the FDA release.
Additionally, data from the FDA’s Sentinel System show serum phosphate testing occurred in fewer than 20% of ferric carboxymaltose injection administration episodes, according to the release.
Hypophosphatemia may manifest differently based on condition severity and duration, with symptoms including muscle weakness or pain, fatigue, tremors, confusion, seizures and cardiac arrhythmias, according to the release. Serious adverse outcomes associated with ferric carboxymaltose injection include hospitalization, a need for prolonged phosphate replacement therapy, osteomalacia and bone fractures.
Clinicians should inform patients about the risk for hypophosphatemia associated with ferric carboxymaltose injection, according to the release. Clinicians should also continue to monitor serum phosphate levels for at-risk patients and consider permanent discontinuation for persistent hypophosphatemia or severe chronic hypophosphatemia, according to the release.
Sources/Disclosures
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Disclosures:
No products or companies that would require financial disclosure are mentioned in this article.
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