An Idaho woman has filed suit against the manufacturers of Injectafer, alleging the iron injections caused her to experience painful and debilitating complications related to dangerously low phosphorous levels.
According to a lawsuit filed in the U.S. District Court, Eastern District of Pennsylvania, on April 24th, Christa Covington was prescribed Injectafer in April 2018 to treat iron deficiency anemia. She subsequently received two infusions on May 3, 2018 and May 10, 2018. (Case No. 2:20-cv-02019)
Covington’s blood phosphorous levels dropped in the aftermath of the second iron injection. On May 19th, her levels measured just 1.6 mg/dl. By May 26th, the levels had fallen to 1.0 mg/dl.
“Plaintiff was subsequently diagnosed with Severe, Symptomatic Hypophosphatemia and, as a result suffered from diffuse pain; muscle spasms; cramping; arthralgias; bone pain; stiffness; weakness; fatigue; paresthesia; nerve pain requiring surgery; sleep disturbance; and rash,” the lawsuit states. As a result of Plaintiff’s severe and ongoing injuries, Plaintiff also had to take multiple weeks off from work and her business suffered.”
The U.S. Food & Drug Administration (FDA) approved Injectafer in 2018. While Injectafer is one of several injectable products indicated to treat iron deficiency anemia in the United States, it alone is formulated with the unique ferric carboxymaltose compound.
Covington’s Injectafer lawsuit claims ferric carboxymaltose is the only such product found to cause severe hypophosphatemia and persistent hypophosphatemia, a fact the defendants have allegedly been aware of for years from clinical trials, as well as an increasing number of case reports and important studies released in the years since the drug won FDA approval.
Despite the growing scientific evidence and the FDA’s own assessment that Injectafer caused “clinically important hypophosphatemia,” the medication was brought to market without adequate warnings on the product labeling or to the medical community. When Covington received her iron injections, the Injectafer label only made passing references to the potential occurrence of hypophosphatemia and no reference at all to severe hypophosphatemia.
“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,” the lawsuit charges.