New research suggests that side effects of Injectafer, an IV medication used to treat iron deficiency, could cause severely low phosphorus levels known as hypophosphatemia (HPP), which can be life-threatening.
In findings published in the August issue of the medical journal Alimentary Pharmacology & Therapeutics, researchers from Norway indicate that Injectafer use was linked to a higher rate of HPP than other treatments for low iron, known as Monofer.
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.
Researchers in this latest study conducted an observational study of 130 patients with inflammatory bowel disease (IBD) treated with Injectafer or Monofer. Iron deficiency and anemia are common complications linked to IBD.
According to the findings, IDB patients given Injectafer showed a significantly higher risk of moderate-to-severe HPP by week two of treatment. The risks continued to increase through weeks six.
At week 2, the incidence of HPP in Injectafer patients was 56.9%, compared to just 5.7% for patients given Monofer. At six weeks, the incidence rate was 13.7% compared to 1.9%, respectively.
Hypophosphatemia can lead to severe health complications, including:
- Cardiac arrest
- Respiratory failure
- Muscle weakness
“In IBD patients with iron deficiency/iron deficiency anaemia, ferric carboxymaltose was associated with higher incidence, severity and persistence of hypophosphatemia compared with iron isomaltoside,” the researchers concluded. “The presence of moderate-to-severe hypophosphatemia beyond 6 weeks is a clinical concern that requires further investigation.”
A number of lawyers are now evaluating the potential for Injectafer lawsuits against the manufacturer, alleging that patients and the medical community were not adequately warned about the HPP risk and other side effects.