FDA Warns About Hospira’s Pediatric Indication on Potassium Phosphates


Hospira/Pfizer’s potassium phosphates product alone may produce daily aluminum exposures of up to twice of the FDA-recommended limit for children.

Although the FDA had been temporarily allowing Hospira’s potassium phosphates injection for pediatric use because of shortages, the agency is now warning healthcare professionals and pharmacies to avoid using Hospira’s drug product in pediatric patients because of potentially high aluminum exposure, regulators said. Hospira’s potassium phosphates product alone may produce daily aluminum exposures of up to twice of the FDA-recommended limit for children, the agency said. Hospira is now owned by Pfizer.

Potassium phosphates are replacement products to correct hypophosphatemia and for parenteral nutrition in adults and pediatric patients.

Pfizer is working quickly to remove the pediatric indication, the company said.

It is also preparing a submission to the FDA for approval of a new potassium phosphates injection product with an aluminum content appropriate for pediatric use.

The FDA recommends healthcare providers use an FDA-approved potassium phosphates injection product with the aluminum content level considered acceptable for each patient based on age, weight, and recommended dose of phosphorus. Fresenius Kabi’s product is appropriate for patients of all ages, FDA noted, as well as CMP Development’s product, for pediatric patients 12 years of age and older who weigh at least 40 kg and adults weighing at least 45 kg. But one of Fresenius Kabi’s products — the 5 mL vial, 25 count — is still showing shortages, according to a recent update by ASHP.

Patients on prolonged courses of parenteral nutrition support are at greatest risk of exposure to toxic levels of aluminum. Exposure to toxic levels of aluminum can lead to softening of the bones, reduced bone mineralization, neurological dysfunction, microcytic hypochromic anemia, and reduction or stoppage of bile flow, according to the FDA.

In December 2022, FDA issued a draft guidance for industry that clarifies the key factors in determining the appropriate aluminum limit in a small volume parenteral drug or pharmacy bulk package for products approved for use in parenteral nutrition. The guidance includes a recommendation that the total allowable aluminum exposure from parenteral nutrition should not exceed 5 mcg/kg/day.

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