According to allegations raised in another product liability lawsuit, side effects of the Injectafer infusion used to treat iron deficiency caused an Ohio man to develop dangerously low phosphorous levels, causing his health to deteriorate.
The complaint (PDF) was filed by James and Melanie Ahern in the U.S. District Court for the Eastern District of Pennsylvania on September 25, present claims against various manufacturers of the anemia drug, including Luitpold Pharmaceuticals, Inc., American Regent, Inc., Daiichi Sankyon, Vifor Pharma, Ltd. and Relypsa Inc.
Ahern indicates he received his first Injectafer infusion in December 2018, for the treatment of his anemia. This was followed by seven additional injections over the course of several months between then and August 2019.
According to the lawsuit, following the first infusion, Injectafer caused his phosphate levels to fall precipitously, resulting in severe and/or symptomatic hypophosphatemia. This led to a deterioration of his health, causing ambulation issues, lower extremity pain, generalized muscle weakness, muscle and joint spasms, joint pain, bone pain, as well as a lumbar spine compression fracture.
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, side effects of the iron infusion have been linked to reports of serious and life-threateningly low phosphorous levels, known as severe hypophosphatemia (HPP).
“Defendants have known for years, even before the pursuit of a New Drug Application (NDA) for Injectafer, that ferric carboxymaltose – and by extension, Injectafer – causes Severe HPP,” the lawsuit states. “During ferric carboxymaltose’s presence on the European and United States markets, dozens of case reports and important pieces of medical literature emerged revealing the dangers of Severe HPP and linked the ferric carboxymaltose compound to Severe HPP.”
Hypophosphatemia (HPP) is an electrolyte disturbance which can cause dangerously low level of phosphate in the blood. Phosphorous is key in bone growth, storage of the body’s energy supply and the growth of muscle and nerves.
When HPP is deemed to be severe, it can cause serious medical complications, including heart problems, cardiac arrest and respiratory failure.
The lawsuit notes that 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. The lawsuit claims the manufacturers knew about these risks but failed to warn the medical community or patients being given the injections.
The case joins a growing number of other Injectafer infusion lawsuits filed in recent months, each involving similar allegations of severe drops in phosphate levels linked to side effects of the iron infusion.