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Injectafer Linked to Severe Hypophosphatemia

Recent research has shown that using Injectafer, a prescription medication for patients with insufficient iron levels could cause a severe case of hypophosphatemia (HPP). This disorder can lead to coma, seizures and death if not treated. And although the U.S. Food and Drug Administration (FDA) updated the warning label in February 2020 to include HPP as a common side effect, that action alone is not enough to adequately warn Injectafer users.

HPP occurs when the body does not receive enough phosphorus. Phosphorus is necessary for energy production, nerve function, and strong teeth and bones. HPP symptoms include unusual fatigue, muscle or bone weakness, seizures and numbness. 

Closeup of the IV drip on the hanger with a patient in a hospital bed

People contract hypophosphatemia in different ways. It can be caused by chronic alcoholism, severe burns, diabetic ketoacidosis (a buildup of harmful acids called ketones) or respiratory alkalosis (low levels of carbon dioxide).

While mild cases can be cured with phosphate supplements or other treatments, severe HPP can be life-threatening, with consequences ranging from red blood cell destruction to respiratory and heart failure.

What Is Injectafer?

First approved for use by the FDA in 2013, Injectafer is an IV medication used to treat adults with iron deficiency anemia. Most anemic patients are women with heavy periods or pregnant women who lose too much iron to their fetus. Others include people who cannot properly absorb dietary iron and those whose overuse of over-the-counter pain relievers leads to internal bleeding. Untreated anemia can result in heart failure, increased susceptibility to infection or premature birth. 

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While oral doses of iron have traditionally been used to treat anemia, it is not always easy for some people to absorb oral medicine. In these cases, doctors may choose to prescribe Injectafer. Typically, it is given in either one or two injections and can stabilize iron levels in a swift manner.

Scientific Trials Show a Need for More Injectafer Communication

While Injectafer is popular for its convenient one or two-dose treatment, several clinical trials linking the drug to substantial phosphorus loss and subsequent HPP are concerning. Two of these studies, published in the February 2020 issue of the Journal of the American Medical Association, found that Injectafer carried a much higher risk of severe HPP than its competitor, Monofer.

The trials were conducted over 35 days and included 245 patients with iron-deficiency anemia. One half was administered Monofer (iron isomaltoside) while the other received Injectafer (ferric carboxymaltose).

In both trials, HPP was observed in less than eight percent of participants given Monofer and more than 73 percent in those given Injectafer. Notably, 11.3 percent of the Injectafer participants developed severe HPP, while none of the Monofer group did. 

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Despite the strong scientific evidence, pharmaceutical companies – continue selling the drug without alerting customers of the substantial risk of HPP. 

Injectafer Lawsuits Filed Against Manufacturers

Injectafer lawsuits have been filed in the U.S. District Court, Eastern District of Pennsylvania, against manufacturers of Injectafer. The defendant companies include Daiichi Sankyo of Japan and its subsidiary, Daiichi Sankyo US; Luitpold Pharma; American Regent; and European-based Vifor Pharma.

Plaintiffs are accusing the drug makers of failing to warn patients of the risks associated with Injectafer. One woman contracted severe HPP after taking Injectafer; she must now take regular phosphate supplements that give her chronic gastrointestinal issues. Another tried to continue working despite her severe HPP symptoms but was forced to take an extended leave. 

Even while Injectafer lawsuits are moving through the Pennsylvania court system, American Regent, the drug’s American manufacturer, has been approved to sell Injectafer to pediatric patients one year old or older.

American Regent cited two clinical trials with child participants in a press release announcing the approval. In the first, less than ten percent of 1,775 patients experienced adverse effects after taking pediatric Injectafer. But in the other, HPP was detected in 13 percent of the children.