Injectafer Lawsuit Filed Over Hypophosphatemia Caused By Iron Infusions

Each iron infusion reportedly left plaintiff debilitated for days or even months at a time.

A product liability lawsuit indicates that a series of iron infusion injections caused a New York woman’s blood phosphorous levels to drop to sharply, resulting in hypophosphatemia from Injectafer side effects.

Tina Clark and her husband, Edward, filed the complaint (PDF) in the Philadephia Court of Common Pleas on October 27, pursuing claims against Luitpold Pharmaceuticals, American Regent, Inc. Daiichi Sankyo, Inc. and Vifor AG as defendants, for failing to warn about the serious medical condition that may result from the iron infusions.

Injectafer (ferric carboxymaltose) is an iron deficiency treatment introduced in 2013, for treatment of adults with anemia who are not able to tolerate oral iron supplements. However, problems after Injectafer infusions have included reports of severe hypophosphatemia (HPP), which can result in potentially life-threatening health complications, including cardiac arrest, respiratory failure, kidney failure and death.

In the lawsuit, Clark indicates she received nine such injections after being diagnosed with iron deficiency anemia in October 2016. The Injectafer injections were given to Clark over the course of about five years; from October 2016 to June 2021. Each iron infusion caused Clark to become debilitated for several days, and sometimes for months, according to the complaint. She now claims this is because she suffered severe and/or symptomatic hypophosphatemia (HPP) caused by the Injectafer injections.

Clark indicates the initial Injectafer label warnings provided for users and the medical community minimized the seriousness of potential drops in blood phosphorus levels that users may experience, which were described as “transient” and “asymptomatic”. However, several studies have found that nearly half of all Injectafer iron treatments result in some level of hypophosphatemia, and if the condition persists or results in severe HPP, it can leave patients with serious and permanent health complications.

“While mild HPP can occur without symptomatology or injury, Severe HPP is a dangerous condition that can cause muscle weakening, severe fatigue, severe nausea, bone and joint pain, and can lead to serious medical complications including osteomalacia, arrhythmias, cardiac arrest, respiratory failure, and/or rhabdomyolysis,” Clark’s lawsuit notes. “The dangers of Severe HPP are not just brought on by the extremely low levels of one’s serum phosphate, but also the duration (or prolonged period) of the Severe HPP.”

The case joins a growing number of similar Injectafer lawsuits now pending in Pennsylvania state court, as well as the U.S. District Court for the Eastern District of Pennsylvania, each involving allegations that plaintiffs experienced severe and debilitating problems after receiving the intravenous (IV) infusion.