Injectafer Fails to Prevent Heart Failure in Patients with Iron Deficiency, Study Finds

There was little difference in rates of death or hospitalization between patients given Injectafer or a placebo, researchers found.

Researchers indicate that administering Injectafer injections to heart failure patients with iron deficiency failed to lower their risk of hospitalization and or death from cardiovascular problems, according to the findings of a new report.

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.

Over the past few years, the manufacturer has faced several hundred Injectafer lawsuits, alleging that false and misleading information was provided about the risks and benefits associated with the iron infusions, including the risk that side effects of Injectafer may cause a dangerous and life-threatening health condition, known as severe hypophosphatemia (HPP).

Plaintiffs allege that if users and the medical community had been adequately warned about the risk and the importance of monitoring blood phosphate levels during treatment, they may have avoided permanent and debilitating injuries.

In a study published on August 26 in The New England Journal of Medicine, researchers from Duke University conducted a double-blinded clinical trial to determine whether Injectafer improved the quality of life for patients who had both iron deficiency and heart failure with reduced ejection fraction.

The randomized clinical trial involved 3,065 subjects, half of whom were given Injectafer injections and half of whom were given a placebo. All of the patients had heart failure, a left ventricular ejection fraction of 40% or less, and iron deficiency.

According to the findings, there was little difference between the two groups after a year of follow-up, with 8.6% of those given Injectafer dying within 12 months, compared to 10.3% among those given a placebo. There was even less difference between patients for hospitalization for heart failure problems, and the reporting of serious adverse events.

They also found that Injectafer use did not improve how far heart failure patients could walk within six minutes. However, researchers noted that repeated doses of Injectafer appeared to be safe for a majority of patients.

“Among ambulatory patients who had heart failure with a reduced ejection fraction and iron deficiency, there was no apparent difference between ferric carboxymaltose and placebo with respect to the hierarchical composite of death, hospitalizations for heart failure, or 6-minute walk distance,” the researchers concluded.