According to allegations raised in a recently filed product liability lawsuit, side effects of Injectafer caused a Florida woman to suffer severely low and life-threatening phosphorous levels, known as severe hypophosphatemia (HPP), after receiving the injection for treatment of low iron.
The complaint (PDF) was filed by Alexis Todd in the U.S. District Court for the Eastern District of Pennsylvania on April 4, naming Luitpold Pharmaceuticals, Inc., American Regent, Inc., Daiichi Sankyo and Vifor Pharmaceuticals Management LTD. as defendants.
According to the lawsuit, Todd was prescribed Injectafer in March 2018, and received two injections for treatment of low iron levels; one in late March and the other in early April of that year.
Todd indicates that after she was given the second shot, her blood phosphorous levels dropped sharply, resulting in a severe HPP diagnosis. She was hospitalized due to fatigue, cramping, paresthesia, chest pain, shortness of breath, bone and joint pain, and weakness. The health problems caused her to discontinue cancer treatment she was undergoing at the time.
The complaint joins a number of similar severe hypophosphatemia (HPP) lawsuits filed in recent months, each raising similar allegations that the manufacturers failed to adequately warn patients or the medical community about the potential health risks from Injectafer.
Todd notes that the warning labels failed to include information about the risk of severe hypophosphatemia from Injectafer, as well as other side effects linked to the condition; including rhabdomyolysis, cardiac arrest, cardiac arrhythmia, and respiratory failure.
“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 lawsuit states. “At the time of Plaintiff’s prescription, the label only made passing references to the potential occurrence of hypophosphatemia and no reference at all to Severe HPP.”
Injectafer (ferric carboxymaltose) was approved for intravenous use by the FDA in 2013. It is an iron replacement by Daiichi Sankyo, meant to treat iron deficiency anemia in adult patients with an intolerance to oral iron supplementation and who have non-dialysis dependent chronic kidney disease.
In August, researchers from Norway reported that side effects of Injectafer were linked to an increased risk of HPP.
Severe hypophosphatemia can lead to severe health complications, including:
- Cardiac arrest
- Respiratory failure
- Muscle weakness