According to allegations raised in a recent filed product liability lawsuit, Injectafer side effects resulted in severely low and damaging phosphorous levels after a North Carolina woman received the iron replacement injection.
The complaint (PDF) was filed by Celeste White late last month in the U.S. District Court for the Eastern District of Pennsylvania, naming Luitpold Pharmaceuticals, Inc., American Regent, Inc., Daiichi Sankyo, and Vifor Pharmaceuticals Management Ltd. as defendants.
Injectafer (ferric carboxymaltose) was approved for intravenous use by the FDA in 2013. It is an iron replacement intended to treat iron deficiency anemia in adult patients with an intolerance to oral iron supplementation and who have non-dialysis dependent chronic kidney disease.
According to allegations raised in the Injectafer lawsuit, White was prescribed the drug in December 2014, after she was diagnosed as suffered from Iron Deficiency Anemia (IDA). She took the injections a total of six times, and indicates that side effects caused her to develop a condition known as severe hypophosphatemia (HPP).
“[P]laintiff was diagnosed with sustained severe hypophosphatemia due to phosphate wasting,” according to the lawsuit. “Her records indicate that this diagnosis was induced by the administration of Injectafer. She was forced to undergo routine and regular monitoring of her phosphorous levels.”
The lawsuit came less than a month after a study by researchers from Norway found that side effects of Injectafer increase the risk of HPP.
The lawsuit indicates the manufacturers knew, or should have known of the risks of HPP from Injectafer, 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.
Hypophosphatemia (HPP) can lead to severe health complications, including:
- Cardiac arrest
- Respiratory failure
- Muscle weakness
White presents claims of negligence, negligent failure to warn, negligent design defect, negligent misrepresentation, fraud, strict liability, breach of warranty, gross negligence and violation of consumer protection laws.