FDA Warnings About HPP Risks Still Insufficient, Critics Say

Posted On July 26th, 2021 By BluShark Digital

The U.S. Food and Drug Administration (FDA) updated the label for the iron replacement medication, Injectafer, in February 2020 to include new information about severe hypophosphatemia (HPP) risks. Unfortunately, their warnings are still lacking and continue to provide misleading information. Among other things, the label fails to fully describe serious and potentially life-threatening side effects experienced after taking Injectafer.

What is Injectafer?

Injectafer was first introduced in the U.S. in 2013, as a prescription iron replacement medication administered directly into a vein via injection or infusion by or under the supervision of a healthcare provider. The medication is given to adult patients with non-dialysis dependent chronic kidney disease whose conditions have not improved with oral iron treatments or could not tolerate the side effects related to these medications.

Once injected into the body, Injectafer is designed to gradually release iron, potentially decreasing side effects and providing patients with more iron after just two treatments. Research has found that less than 10 percent of oral iron is actually absorbed into the digestive system, even in healthy patients. However, Injectafer is by no means side effect free.

New Label Issues

In 2018, an updated FDA label was issued. This label removed previous language suggesting that HPP side effects were occasional or minor. New warnings were also added to the Patient Information Sheet, acknowledging low levels of phosphorous in the blood to be a common side effect of Injectafer.

In February 2020, the latest Injectafer label provided added information about the HPP risk to the Warnings and Precautions section. Although this latest label is an improvement over initial warnings regarding HPP risks, patients and the medical community are still receiving false and misleading information concerning severe reductions in phosphorus levels after an infusion. However the FDA provided no additional information about the symptoms of mild or moderate HPP or the serious injuries that may result from persistent or severe HPP.

Childers, Schlueter & Smith is not currently litigating Injectafer, but as research is still developing, and each person’s situation may vary, give us a call to see if we can help. You can also contact us via our contact us page or by calling 404-419-9500.

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