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After receiving multiple injections of the low iron treatment Injectafer, a Pennsylvania woman indicates in a recently filed lawsuit that she developed chronically low blood phosphorous levels which caused muscle problems, kidney failure and other side effects from Injectafer, which left her dependent on a walker.
The complaint (PDF) was filed by Julie Hansen earlier this month in the U.S. District Court for the Eastern District of Pennsylvania, alleging that Luitpold Pharmaceuticals, American Regent, Inc. Daiichi Sankyo and Vifor International failed to provide adequate warnings about the importance of monitoring serum phosphorus levels after Injectafer treatments, and the risk that severely decreasing levels may result in a medical condition known as severe hypophosphatemia (HPP).
Hansen was prescribed Injectafer (ferric carboxymaltose) in June 2019, for the treatment of her iron deficiency anemia (IDA) and she received two injections that month. Soon thereafter, Hansen began to experience symptoms that were indicative of severe or symptomatic hypophosphatemia, but her doctors did not immediately know the cause of her failing health, since the Injectafer FDA warnings failed to include information about the risk.
According to the lawsuit, Hansen developed leg edema, muscle cramping, kidney failure, extremity weakness and pain, numbness, depression, anxiety and antalgic gait that has resulted in the use of a walker.
“Failure to warn of Severe HPP, along with the injuries it can cause – osteomalacia, rhabdomyolysis, cardiac arrest, cardiac arrhythmia or respiratory failure – given their clinical significance and Defendants’ knowledge of the frequency at which they occur in Injectafer users, is a complete derogation of Defendants’ responsibilities to properly warn of Injectafer’s known dangers in violation of all relevant state and federal laws,” Hansen indicates in the complaint.
The case joins a growing number of similar Injectafer iron treatment lawsuits filed in recent years by individuals who experienced problems after receiving the intravenous (IV) infusion.
Injectafer was introduced in 2013, as an iron infusion treatment for adults with anemia who are not able to be treated with an oral iron supplement, and have non-dialysis dependent chronic kidney disease.
Although initial warnings provided for users and the medical community minimized the seriousness of potential drops in blood phosphorus levels, which were described as “transient” and “asymptomatic”, several studies have found that nearly half of all Injectafer iron treatments result in some level of hypophosphatemia, and if the condition persists or results in severe HPP, it can leave patients with serious and permanent health complications.
Hansen presents claims of negligence, negligent failure to warn, negligent design defect, negligent misrepresentation, and fraud. She is seeking both compensatory and punitive damages.