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According to allegations raised in a product liability lawsuit filed last month, the side effects of Injectafer left a California man with critically low and unstable blood phosphate levels after just one injection of the iron deficiency drug.
The complaint (PDF) was brought by Gregory Yova in the U.S. District Court for the Eastern District of Pennsylvania last month, presenting claims against Luitpold Pharmaceuticals, Inc., American Regent, Inc. Daiichi Sankyo, Inc. Vifor Pharma, Ltd. and Relypsa Inc. as defendants.
Yova indicates he received an Injectafer injection in November 2019, in order to treat iron deficiency anemia. However, after the first treatment, his phosphate levels dropped to levels indicative of severe and symptomatic hypophosphatemia (HPP), which is a serious and potentially life threatening condition.
“As a result, Plaintiff’s health began to deteriorate, leading to a hospitalization and physical restrictions,” Yova’s lawsuit states. “Despite aggressive IV Phosphate replenishment and oral supplementation, Plaintiff’s phosphate levels continue to be unstable.”
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, side effects of the iron infusion have 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.
Yova’s 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 in recent months, each involving similar allegations of severe drops in phosphate levels linked to side effects of the iron infusion.