A Florida woman who suffered a severe drop in blood phosphorus following treatment with Injectafer has filed a new lawsuit alleging the iron injections were to blame for the life-threatening complications she experienced.
According to an Injectafer lawsuit filed in the U.S. District Court, Eastern District of Pennsylvania, on April 4th, Alexis Todd was prescribed Injectafer to treat iron deficiency anemia she developed while undergoing treatment for cancer. She received two Injectafer infusions in late March and early April of 2018. (Case No. 2:20-cv-01759)
Todd’s phosphorus levels dropped sharply after the second treatment, resulting in a diagnosis of severe hypophosphatemia. She was subsequently hospitalized for fatigue, cramping, paresthesia, chest pain, shortness of breath, bone and joint pain, and weakness. Todd was also forced to discontinue her cancer treatment.
“Injectafer’s label omits, and has at all relevant times since its introduction into the United States market, any reference to Severe HPP or ‘clinically important hypophosphatemia.’” The labeling makes no attempt to inform the user and medical community of the clinical differences between the varying levels of hypophosphatemia.” The complaint states. “At the time of Plaintiff’s prescription, the labeling did not inform the user or medical community how to monitor serum phosphorous levels so as to be on alert for severely decreasing levels that may result in Severe HPP or additional injury.”
The U.S. Food & Drug Administration (FDA) approved Injectafer in 2013, after initially rejecting the medication out of concern for “excess mortality and severe hypophosphatemia.”
Over the last several years,, evidence linking Injectafer to dangerously low phosphorous levels has only grown more compelling. Last February, for example, the results of two clinical trials published in the Journal of the American Medical Association (JAMA) indicated that hypophosphatemia and severe hypophosphatemia occurred more frequently among subjects treated with Injectafer compared to those who received another iron injection called Monofer.
In December 2018, researchers writing in the Journal of Clinical Investigation suggested more than half of those treated with Injectafer will develop severe hypophosphatemia. And just two years earlier, Austrian researchers reported that hypophosphatemia had occurred in 45% of those treated with Injectafer, while 32% developed severely low phosphorous levels.
Severe hypophosphatemia occurs when blood phosphorous levels fall below 1mg/dL. Symptoms typically include:
If left untreated, severe hypophosphatemia can result in respiratory failure, muscle weakness, cardiac arrest, seizures, coma, and even death.