Injectafer Approved For Single Dose Iron Infusion Treatment, As Lawsuits Over Severe HPP Mount

Amid growing concerns over the side effects of Injectafer iron infusions, which have been linked to dangerous drops in blood phosphorous levels and severe medical complications, federal regulators have approved a single dose of the intravenous treatment for iron deficiency anemia.

In a press release issued earlier this month, Daiichi Sankyo and its American Regent subsidiary announced that the FDA has granted approval for a 1,000 mg single-dose treatment of Injectafer.

Injectafer (ferric carboxymaltose) was introduced in 2013, as an iron infusion for adults with anemia, who are not able to be treated with an oral iron supplement and have non-dialysis dependent chronic kidney disease. Patients usually require at least two 750 mg infusions, spaced at least seven days apart. However, some patients undergo repeated infusions if symptoms of anemia persist.

A number of independent studies and case reports published in recent years have highlighted problems following Injectafer iron infusion treatments, where users developed severe hypophosphatemia, which involves dangerously low blood phosphorous levels, which can result in repeated hospitalizations, cardiac arrest, respiratory failure, osteomalacia, rhabdomyolysis and death.

In February 2020, the drug makers added new warnings about the risks, recommending that serum phosphate levels be monitored among patients who require repeat courses of the iron infusion.

This new approval provides for a larger single dose of 1,000 mg, which can be given during one infusion treatment, as opposed to two courses of the iron injection spaced seven days apart, for a cumulative dose of 1,500 mg.

Daiichi Sankyo and American Regent currently face a growing number of Injectafer lawsuits being pursued by patients who allege that they would have avoided severe injuries if earlier warnings had been provided about the risk of severe hypophosphatemia (HPP) and the importance of monitoring for drops in blood phosphorous levels..

It is unclear from statements provided by the drug makers what impact the single dose regimen may have on the HPP risks following Injectafer iron infusion treatments, or whether it may impact the need for multiple courses of the injections to effectively treat iron deficiency anemia (IDA).

According to the press release, the single dose regimen will become available in the coming weeks.