Severe Hypophosphatemia (HPP) Lawsuit Filed Over Injectafer Iron Deficiency Treatment

Drug manufacturers failed to warn about the risks of Injectafer iron deficiency treatment, the severe HPP lawsuit claims

A New York woman has filed a product liability lawsuit over the development of severe hypophosphatemia (HPP) from Injectafer, alleging the iron deficiency treatment caused dangerous drops in phosphate levels, leading to severe joint, bone and muscle pain, as well as generalized weakness and fatigue that will continue to impact her in the future.

Injectafer (ferric carboxymaltose) has been marketed as a safe and effective anemia treatment since 2013, which is typically administered to adults experiencing iron deficiency, who are not able to manage the condition with an oral iron supplement or have non-dialysis dependent chronic kidney disease.

The complaint (PDF) was filed by Dena Ellis in the Pennsylvania Court of Common Pleas on December 7, claiming that the drug makers failed to warn adequately warn users and the medical community about the risk of severe hyposphosphatemia (HPP) from Injectafer, and the importance of monitoring blood phosphate levels during treatment.

The case filed by Ellis will join several hundred similar Injectafer lawsuits currently being pursued against the drug makers Luitpold Pharmaceuticals, American Regent, Inc., Daiichi Sankyo, Inc. and Vifor International AG, seeking damages for concealing vital safety information and delaying warnings that could have avoided severe and permanent injuries associated with critically low phosphate levels.

Ellis indicates she was prescribed Injectafer for the treatment of iron deficiency anemia in September 2020, and she received two infusions of the iron deficiency treatment within a week of each other that month.

“Subsequent to Plaintiff’s Injectafer use, Plaintiff’s phosphate levels dropped to critically low levels, and she suffered symptoms indicative of severe and/or symptomatic hypophosphatemia,” the lawsuit states. “As a result of her use of Injectafer, Plaintiff has suffered, and will likely suffer in the future, severe and permanent injuries and damages, including, but not limited to: severe hypophosphatemia, generalized fatigue and weakness, joint, bone and muscle pain, vitamin D deficiency, stress and anxiety.”

Hypophosphatemia (HPP) is an electrolyte disturbance in which blood tests reveal that there is an abnormally low level of phosphate in the blood. However, the risks caused by the condition are not just related to the extremely low levels of serum phosphate, but also can leave users with long-term Injectafer side effects depending on the duration of the problems.

Ellis’ lawsuit claims the manufacturers have long known about the risks of severe HPP linked to Injectafer, but they failed to warn either the medical community or patients about the risks of the iron deficiency treatment.

When the drug was first introduced in 2013, the Injectafer warning label described reports of serum phosphate drops as “asymptomatic” or “transient.” In 2018, that warning was upgraded, but only suggested hypophosphatemia side effects were mild and infrequent.

It was not until February 2020 that the warnings about Injectafer side effects (PDF) were updated to add more detailed information about the risk of symptomatic hypophosphatemia caused by the iron infusion. However, critics have said even those warnings remain inadequate.