Side effects of the iron deficiency treatment Injectafer caused a Florida woman to experience dangerous drops in phosphorous levels, resulting in a condition known as severe hypophosphatemia, according to allegations raised in a recently filed product liability lawsuit.
The complaint (PDF) was filed last week by Tracy Schenk in the U.S. District Court for the Eastern District of Pennsylvania, indicating that the drug makers Luitpold Pharmaceuticals, Inc., American Regent, Inc., Daiichi Sankyo and Vifor Pharma failed to adequately warn users about the potential Injectafer problems.
Schenk was prescribed the injections in March 2016, after she was diagnosed with iron deficiency anemia. She received eight injections between March and late September of that year, indicating in the lawsuit that side effects of Injectafer caused her chest pains, palpitations, shortness of breath, insomnia, tachycardia, pain in her back, neck and knees, as well as a general deterioration of her health associated with severe hypophosphatemia.
“These injuries disrupted Plaintiff’s ability to enjoy life and have continued since she stopped receiving Injectafer,” the lawsuit states. “Plaintiff’s severe and permanent injuries have impaired, and continue to impair, her daily activities.”
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.
Injectafer (ferric carboxymaltose) was introduced by Daiichi Sankyo 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 injection have been linked to reports of serious and life-threateningly low phosphorous levels.
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 lawsuits filed in recent months, each involving similar allegations of severe drops in phosphate levels linked to side effects of the iron infusion.