FDA Adds Boxed Warning to Ferric Carboxymaltose Following Petition Led by Cure HHT’s Dr. Scott Olitsky
When something in HHT care isn’t working the way it should, speaking up matters.
On August 13, 2026, the US Food and Drug Administration (FDA) granted a citizen petition submitted by Scott Olitsky, MD, MBA, Cure HHT’s Global Center of Excellence and Outreach Director, calling for stronger safety warnings for ferric carboxymaltose, commonly known by the brand name Injectafer and Ferinject
As a result, the FDA has approved a new boxed warning—sometimes called a “black box warning”—about the risk of hypophosphatemia, or dangerously low phosphate levels in the blood, and the serious complications that can sometimes follow.
For people living with HHT, this issue hits especially close to home.
Chronic nosebleeds and gastrointestinal bleeding make iron deficiency and iron-deficiency anemia a reality for many people in our community. Many require IV iron supplementation not just once, but repeatedly over months or years. That makes understanding the safety profile of the iron products used in HHT care incredibly important.
Turning an HHT Concern Into Action
Dr. Olitsky’s petition asked the FDA to strengthen warnings around FCM because of its association with hypophosphatemia and the potential consequences of severe or prolonged phosphate depletion.
For some people, low phosphate may be temporary. For others, it can become severe or persist over time, contributing to muscle weakness, bone pain, difficulty walking, osteomalacia, fractures and, in serious cases, potentially life-threatening complications.
There is another challenge for people with HHT: symptoms like fatigue and weakness can look a lot like the symptoms of iron deficiency itself. That can make low phosphate harder to recognize without appropriate monitoring.
The FDA had already strengthened Injectafer’s safety information in previous years. But after reviewing new evidence—including adverse-event reports, published research and real-world laboratory data—the Agency determined that stronger action was needed.
Its review identified 134 reports and published cases of serious, symptomatic hypophosphatemia associated with ferric carboxymaltose between July 1, 2022 and June 30, 2025. Some of those cases were severe, prolonged, difficult to treat or associated with serious outcomes.
The FDA also found that phosphate testing was happening far less often than expected, even though previous prescribing information already recommended monitoring for certain patients at increased risk.
Together, that evidence led the FDA to grant Dr. Olitsky’s petition.
For our community, this is more than a labeling change. It is a powerful example of what can happen when someone who understands the realities of HHT care recognizes a problem, follows the evidence and keeps pushing for safer care.
“Dr. Olitsky saw something that mattered for people with HHT and refused to let it be overlooked. His leadership on this petition shows exactly why HHT expertise is so important—not only for our own community, but for every patient who may benefit from safer, better-informed care. We are incredibly grateful for his persistence and commitment to patients.”
— Marianne Clancy, CEO, Cure HHT
Summary for Healthcare Professionals
For clinicians caring for people with HHT, the key change is that Injectafer (ferric carboxymaltose) now carries a boxed warning for hypophosphatemia, with stronger guidance around phosphate monitoring. The updated labeling recommends checking serum phosphate in patients at risk for low phosphate and in any patient receiving a repeat course of Injectafer within three months. It also clarifies that symptomatic hypophosphatemia has occurred after both single and multiple doses, including in patients without apparent risk factors. Patients who develop severe symptomatic or persistent hypophosphatemia should permanently discontinue Injectafer.
This is especially relevant in HHT, where chronic blood loss can mean repeated IV iron treatment over many years. When selecting an IV iron formulation, clinicians should consider not only how effectively it replaces iron, but also the potential risks associated with repeated exposure. Symptoms such as fatigue and weakness may also overlap with iron-deficiency anemia, making appropriate monitoring and early recognition particularly important.
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Summary for Patients, Caregivers, and the General Public
If you receive Injectafer for iron deficiency or anemia, the new boxed warning does not mean you should stop treatment. It means the FDA is making the risk of low phosphate more visible so patients and healthcare professionals can make informed decisions and monitor when needed. Low phosphate can sometimes cause symptoms such as muscle weakness, bone pain or difficulty walking, and severe or long-lasting cases can lead to more serious complications.
For people with HHT—especially those who receive IV iron repeatedly—it is worth knowing which type of IV iron you receive and talking with your care team about whether phosphate testing is appropriate for you. Because symptoms like fatigue and weakness can look similar to iron deficiency itself, be sure to tell your healthcare provider about new or worsening symptoms after an infusion. Do not stop or change your iron treatment without speaking with your care team.
Looking for additional information? Access our previously published FAQ about these changes.