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A Georgia woman has filed a product liability lawsuit against the makers of Injectafer, indicating that, after receiving a dozen injections of the iron deficiency drug, she suffered severe and persistent drops in blood phosphate levels, known as hypophosphatemia (HPP), which left per with numerous health issues.
The complaint (PDF) was filed by Malcolma Ward in the U.S. District Court for the Eastern District of Pennsylvania, presenting claims against Luitpold Pharmaceuticals Inc., American Regent, Inc. Daiichi Sankyo, Inc, and Vifor International AG as defendants.
Ward indicates she was prescribed Injectafer in August 2016, due to her low iron levels. Between then and January 2017, she received at least 12 injections. However, she then began suffering symptoms of the blood phosphate problems
According to the lawsuit, the Injectafer hypophosphatemia side effects left Ward with a variety of health complications, including severe muscle fatigue, weakness, severe and prolonged pain, nausea, chills, headaches and restless leg syndrome, which she blames on the
Injectafer (ferric carboxymaltose) was introduced in 2013, as an iron infusion for adults with anemia, who are not able to be treated with an oral iron supplement and have non-dialysis dependent chronic kidney disease. However, the iron infusion has been linked to reports of HPP. When this condition is severe, it can result in serious medical complications, including heart problems, cardiac arrest and respiratory failure.
According to the lawsuit, Injectafer is the only anemia treatment on the U.S. market which contains a unique ferric carboxymaltose (FCM) compound, which is known to cause severe HPP and potentially persistent HPP. The lawsuit claims the manufacturers knew about these risks but failed to warn the medical community or patients being given the injections.
“Defendants have known for years, even before the pursuit of a New Drug Application (NDA) for Injectafer, that ferric carboxymaltose – and by extension, Injectafer – causes Severe HPP,” Ward’s lawsuit states. “During ferric carboxymaltose’s presence on the European and United States markets, dozens of case reports and important pieces of medical literature emerged revealing the dangers of Severe HPP and linked the ferric carboxymaltose compound to Severe HPP.”
The lawsuit claims the manufacturers failed to provide adequate label warnings, which should have alerted doctors and patients to the risk of severe HPP, as well as the injuries it can cause, including osteomalacia, rhabdomyolysis, cardiac arrest, cardiac arrhythmia and respiratory failure.
The case joins a growing number of other Injectafer lawsuits filed over the past year, each involving similar allegations of severe drops in phosphate levels linked to side effects of the iron infusion.