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Girl in hospital with IV fluids

FDA warns of aluminum exposure from unapproved potassium phosphates drug product

February 9, 2023

Clinicians and pharmacists should not use Hospira’s unapproved potassium phosphates drug product in children due to its aluminum levels, according to a new warning from the Food and Drug Administration (FDA).

The potassium phosphates injections are intended as a source of phosphorus in IV fluids to correct low phosphate levels and for parenteral nutrition in adults and pediatric patients. However, Hospira’s product may expose children to twice the FDA-recommended limit of daily aluminum for parenteral nutrition, the FDA said.

Instead, health care providers should use an FDA-approved phosphates injection product. The FDA considers Fresenius Kabi’s product appropriate for patients of all ages and CMP Development’s product appropriate for adolescents 12 years and older who weigh at least 40 kilograms (kg) and adults weighing at least 45 kg.

Detailed dosing instructions for preparation and administration are provided with these products to minimize the risks of aluminum toxicity. Exposure to toxic levels 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. Patients on prolonged courses of parenteral nutrition support are at the greatest risk.

Adverse events from potassium phosphates drug products or any medicine should be reported to the FDA’s MedWatch Adverse Events Reporting program.

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