Injectafer Warning Label Downplayed Risk of Iron Infusion Causing Hypophosphatemia, Lawsuit Alleges

Hypophosphatemia lawsuit alleges that woman would have avoided dangerous drops in blood phosphate levels if adequate Injectafer warnings had been provided

According to allegations raised in a recently filed lawsuit, the Injectafer warning label has minimized the risk of severe hypophosphatemia (HPP), which caused a Wisconsin woman to experience dangerous drops in blood phosphorous levels after the iron infusion.

The complaint (PDF) was filed by Larosa Jones in the U.S. District Court for the Eastern District of Pennsylvania on September 26, pursuing claims against the drug manufacturers Luitpold Pharmaceuticals, Inc., American Regent, Inc., Daiichi Sankyo, Inc. and Vifor International AG, as defendants.

Injectafer (ferric carboxymaltose) has been marketed by the drug makers since 2013, as an iron infusion treatment 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, long-term side effects of Injectafer have been linked to reports of severe hypophosphatemia (HPP), which is a medical condition associated with drops in blood phosphate levels, increasing the risk of severe health complications like cardiac arrest, respiratory failure and death.

As a result of the drug makers failure to adequately warn about these risks for years after the iron infusion was approved, a growing number of former users are now pursuing an Injectafer lawsuit, indicating that they may have avoided severe and debilitating problems if hypophosphatemia warnings had been provided about the importance of blood phosphate testing after treatments.

Jones indicates that she was prescribed an Injectafer infusion for the treatment of iron deficiency anemia in April 2016, receiving injections in May, June and November of that year. Following those infusions, she began to experience problems and alleges that Injectafer caused hypophosphatemia symptoms that have left her with long-term side effects.

Injectafer Warnings Were Inadequate

The lawsuit indicates it took years, and media attention, before Jones realized Injectafer could have caused her health problems, and notes that her lack of knowledge was a direct result of the drug makers failure to provide users with adequate Injectafer warnings.

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 Injectafer warning label (PDF) added more detailed information about the risk of symptomatic hypophosphatemia caused by the iron infusion. However, Jones indicates even that remains inadequate and fails to bring the problems to the attention of users.

“At the time of Plaintiff’s prescription, the label only made passing references to the potential occurrence of hypophosphatemia, downplayed its risk, and made no reference at all to Severe HPP,” the lawsuit states. “When the label did reference the potential adverse reaction of regular hypophosphatemia, it significantly downplayed the risk and potential for injury thus confusing and nullifying the nature of any potential warning.”

While the updated warnings provided in February 2020 recommended doctors monitor serum phosphate levels among patients at risk of problems or who require repeat courses of the iron infusion, a growing number of experts now suggest doctors should be encouraged to test blood phosphate levels for all Injectafer patients.

Injectafer Lawsuit October 2022 Update

The Injectafer lawsuit filed by Jones will be coordinated with more than 100 other claim spending in the U.S. District Court for the Eastern District of Pennsylvania, which each raise similar allegations regarding problems with the iron infusion warning label.

Although the Injectafer litigation is not formally centralized as part of an MDL, the pretrial proceedings are being coordinated before one judge to avoid duplicative discovery and conflicting pretrial schedules.

In September 2022, U.S. District Judge Wendy Beetlestone scheduled the first Injectafer hypophosphatemia lawsuit for trial to begin on June 5, 2023, involving claims brought by Katherine Crockett.

While the outcome of the trial will not have a binding effect on the lawsuit filed by Jones and other plaintiffs, the outcome is expected to have a big impact on potential Injectafer settlement agreements that may be reached to avoid the need for each individual case to go before a jury.