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A Texas woman indicates in a recently filed lawsuit that the side effects of Injectafer, an iron deficiency and anemia drug, resulted in dangerously low levels of phosphorous, known as severe hypophosphatemia (HPP).
The complaint (PDF) was filed By Barbara Kessler and her husband, Thomas, in the U.S. District Court for the Eastern District of Pennsylvania on February 18, naming Luitpold Pharmaceuticals, Inc., American Regent, Daiichi Sankyo, Inc., Vifor Ltd, and Relypsa Inc. as defendants.
Kessler, who suffers from iron deficiency anemia, was prescribed Injectafer in February 2016, and received the iron infusions every two to six weeks, until she ultimately received 35 separate doses.
According to the lawsuit, Injectafer caused chronic, severe, and symptomatic HPP, which left her with bone pain, fatigue, shortness of breath and weakness for three years. Although she contacted her doctor about the possible link to Injectafer, neither her doctor or other members of the medical community were ever made aware of these potential problems.
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, problems after an Injectafer infusions have included reports of severe HPP, which can result in severe health complications, including cardiac arrest, respiratory failure and death.
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.
“Injectafer’s label currently, and at all relevant times since its introduction into the United States market, omits any reference to Severe HPP or ‘clinically important hypophosphatemia’ and generally omits reference to the type of serious complications that can result from Severe or Persistent HPP,” the lawsuit states. “The labeling does not attempt to inform the user and medical community of the clinical differences between the varying levels of hypophosphatemia.”
Kessler 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 infusion lawsuits filed over the past year, each involving similar allegations of severe drops in phosphate levels linked to side effects of the iron infusion.