A lawsuit filed on September 25 in federal court in Pennsylvania alleges that Injectafer injections led to hypophosphatemia which deteriorated an Ohio’s man health, leading to side effects including a lumbar spine compression fracture. The lawsuit names American Regent, Inc., Daiichi Sankyo, Inc., Vifor Pharma Ltd. and their subsidiaries as defendants.
Injectafer is an iron deficiency treatment. The lawsuit claims the man received an Injectafer injection on or around December 20, 2018 and seven more injections until August 27, 2019.
The man’s phosphate levels dropped to “critically low levels” after the first set of injections, according to the complaint, which says he “suffered symptoms indicative of severe and/or symptomatic hypophosphatemia.” The complaint says his health deteriorated as a result, leading to a lumbar spine compression fracture, bone pain, joint pain, joint and muscle spasms, generalized muscle weakness, lower extremity pain and ambulation issues.
The complaint states the man was diagnosed with hypophosphatemia, hypophosphatemic osteomalacia and avascular necrosis of the hip bone after the final Injectafer treatment.
Hypophosphatemia is essentially a shortage of phosphate in the blood. It is listed on Injectafer’s label as an adverse reaction.
The complaint notes that “there are clinically significant differences between mild hypophosphatemia (2.0 – 2.5 mg/dl) and severe hypophosphatemia (less than 1.5, 1.3, or 1.0 mg/dl). While moderate HPP may occur with or without symptomatology or injury, Severe HPP is a dangerous diagnosis that carries with it muscle weakening, fatigue (potentially severe), severe nausea, and can also lead to serious medical complications including osteomalacia, arrhythmias, cardiac arrest, respiratory failure, and/or potentially rhabdomyolysis.”
Injectafer’s label does not warn of a risk of severe hypophosphatemia, nor the serious medical complications that can result from severe hypophosphatemia.
The complaint says that the defendants “have known for years” that Injectafer causes severe hypophosphatemia,” yet failed to warn the public and the plaintiffs about this risk.
The complaint notes that “dozens of case reports and important pieces of medical literature” have linked Injectafer to severe hypophosphatemia.
The complaint references several studies linking Injectafer to severe hypophosphatemia. All 18 cases of severe hypophosphatemia in a comparison between Injectafer and Monofer occurred after administration of Injectafer in one study. 32.7% of Injectafer recipients in that study developed severe hypophosphatemia.
58.8 percent of Injectafer users developed severe hypophosphatemia in another study cited by the complaint.
The complaint states that Injectafer had been denied FDA approval in the past due to safety concerns including “clinically important hypophosphatemia,” a condition which never found its way onto Injectafer’s label even though it was a reason the FDA had denied the treatment’s approval.