WHAT IS INJECTAFER?
Ferric carboxymaltose, labeled and marketed as Injectafer, is an IV medication prescribed for adults with iron deficiency anemia (the most common type of anemia), who have been unable to tolerate oral iron supplements or who have non-dialysis dependent chronic kidney disease.
Iron is important for the body’s production of red blood cells (hemoglobin), which carry oxygen in your blood from your lungs to other tissues. Iron is also for myoglobin, a red protein that carries and stores oxygen in muscle cells. Patients with anemia do not produce enough red blood cells. There are five main types of anemia. The most common is iron deficiency anemia, which affects millions of Americans.
Injectafer is a prescribed iron replacement medication. It is administered by IV, usually in two doses at least 7 days apart. Injectafer (ferric carboxymaltose) is not the only IV iron formulation available for patients. Several other formulations are available, including ferumoxytol.
HOW IS INJECTAFER LINKED TO SEVERE AND EXTREME HPP?
Although Injectafer was approved by the FDA in 2013, post-market surveillance has shown that ferric carboxymaltose causes severe hypophosphatemia far more often than other IV iron therapy medications.
A scientific study published in the Journal of Clinical Investigation – Randomized Trial of IV Iron-Induced HPP– demonstrated that patients given ferric carboxymaltose suffered HPP much more often than patients given the alternative medication ferumoxytol. Among the Injectafer patient group, over half (50.8%) of patients developed HPP. In the ferumoxytol patient group, only 0.9% developed HPP.
WHAT IS HPP EXACTLY?
HPP is an abnormally low level of the electrolyte phosphate in the bloodstream. Phosphate is important to the body for several reasons. It serves a critical purpose in nerve function, healthy bones, and energy production. HPP can be detected by clinical markers (symptoms) and serum levels of phosphate concentration. When present, HPP is categorized as mild, moderate, severe, or extreme.
Cases of mild and moderate HPP usually are not detected because they do not cause symptoms. But severe and extreme HPP produces symptoms such as:
• Bone pain
• Bone fractures
• Tooth decay
• Muscle weakness
• Appetite loss
If HPP is not timely treated, it can lead to serious complications, including death, cardiac arrest, seizures, respiratory failure, and ischemia or death of muscle tissue.
FDA WARNING TO INJECTAFER MANUFACTURER
American Regent, Inc. manufactures Injectafer. American Regent is a subsidiary of Luitpold Pharmaceuticals, Inc. The FDA sent a letter to Luitpold Pharmaceuticals in 2015 warning the company that its marketing of the drug was misleading, omitted material facts, and minimized the drug’s risks.
Luitpold Pharmaceutical’s marketing conduct is particularly troubling given the findings in the scientific literature that over half of patients receiving Injectafer developed HPP, whereas a competitor product resulted in an HPP incidence rate of 0.9%.
WHAT SHOULD I DO?
If you would like to speak with one of our Injectafer attorneys, call (205) 879-5000
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