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An Iowa woman has filed a product liability lawsuit over side effects of the iron deficiency anemia (IDA) drug Injectafer, indicating the manufacturer failed to warn that the injection may result in severely low and dangerous phosphorous levels.
Mary Woodford filed the complaint (PDF) in the U.S. District Court for the Eastern District of Pennsylvania on October 5, presenting claims against Luitpold Pharmaceuticals, American Regent, Inc., Daiichi Sankyo, Inc. and Vifor Pharma, LTD., as defendants.
Injectafer (ferric carboxymaltose) was introduced by Daiichi Sankyo in 2013, as an iron deficiency anemia (IDA) infusion for adults who unable to be treated with an oral iron supplement and have non-dialysis dependent chronic kidney disease. However, side effects of Injectafer have been linked to reports of serious and life-threateningly low phosphorous levels, known as severe hypophosphatemia (HPP).
This complication of the iron injection involves 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.
Woodford, who suffers from anemia, was prescribed Injectafer in April 2019 and received her first injection that month, another in May 2019, and a third in July of that same year.
Following the iron deficiency injections, Woodford began suffering symptoms of severe hypophosphatemia. However, the lawsuit indicates the manufacturers never warned this was a risk associated with the medication, nor did it advise doctors and patients that phosphorous levels should be watched closely.
“The labeling makes no attempt to inform the user and medical community of the clinical differences between the varying levels of hypophosphatemia,” the lawsuit 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 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.