According to allegations raised in a product liability lawsuit brought against the makers of Injectafer, consumers and the medical community have not been adequately warned about the potential side effects of the iron deficiency drug, which has been linked to a risk of severely low and life-threatening phosphorous levels, known as severe hypophosphatemia.
The complaint (PDF) was filed earlier this month in the U.S. District Court for the Eastern District of Pennsylvania by Maria Munroe and her husband, Anthony, indicating that Injectafer is unreasonably dangerous and defective. The lawsuit names Daiichi Sankyo, its subsidiaries American Regent and Luitpold Pharmaceuticals, Inc., and Vifor Pharmaceuticals Management LTD., as defendants.
Monroe indicates that she was prescribed the Injectafer iron deficiency drug in September 2018. After receiving two injections, she began to suffer severely low levels of phosphorous, which resulted in hospitalization and the need for IV phosphate infusions. However, in late October 2018 she was also diagnosed with increased phosphate renal excretion and her phosphate levels failed to stabilize.
Munroe has been diagnosed with chronic or persistent hypophosphatemia (HPP), which the lawsuit blames on the side effects of Injectafer. As a result of the problems, she has been hospitalized three times and must continue to take daily phosphate supplements.
Injectafer (ferric carboxymaltose) was approved for intravenous use by the FDA in 2013. It is an iron replacement by Daiichi Sankyo, meant to treat iron deficiency anemia in adult patients with an intolerance to oral iron supplementation and who have non-dialysis dependent chronic kidney disease.
In August, researchers from Norway reported that side effects of Injectafer were linked to an increased risk of HPP.
The lawsuit indicates the manufacturers knew, or should have known of the risks of HPP, but failed to provide adequate warning to the medical community or patients. It also notes that with the failure to warn of HPP, the label also fails to warn of the potential injuries which could result.
“Defendants, as the entities responsible for the Injectafer product and labeling, had a duty to warn potential users of Injectafer’s known risks of Severe HPP, as well as the injuries that can result from Severe HPP, and also Injectafer’s known propensity to increase FGF23 which in turn can cause both acute and potentially prolonged Severe HPP,” Munroe’s lawsuit states. “Defendants at no times have attempted to warn users of these risks and have therefore violated their duties to warn and not misrepresent the benefits of a drug.”
Hypophosphatemia can lead to severe health complications, including:
- Cardiac arrest
- Respiratory failure
- Muscle weakness
The case joins a growing number of other Injectafer lawsuits being pursued by individuals who have experienced problems or side effects after receiving the iron deficiency drug.