In a recent statement, the US Food and Drug Administration warned pharmacies and health care providers about unsafe aluminum levels for pediatric patients in Hospira’s unapproved potassium phosphates drug product.
The US Food and Drug Administration (FDA) has cautioned pharmacies and health care professionals against giving pediatric patients an unapproved potassium phosphates drug product from Hospira, citing dangerous levels of aluminum for infants in the product.
According to the FDA, infants may be exposed to twice the recommended limit of daily aluminum from this product alone, with other aspects of parenteral nutrition increasing aluminum exposure further. Providers should instead offer a potassium phosphates injection product approved by the FDA.
Products used should be based on the acceptable aluminum level for patient weight, age, and recommended phosphorus dosage. One product from Fresenius Kabi is considered appropriate for use in all age groups by the FDA. Another product from CMP Development is considered appropriate for use in patients 12 years and older weighing 40 kg or more.
Detailed dosing and administration instructions are present for these FDA-approved products, reducing the risk of aluminum toxicity. Potassium phosphates injections are used in adults and pediatric patients to supply phosphorus in IV fluids for hypophosphatemia corrections and parenteral nutrition.
Prolonged exposure to parenteral nutrition support leads to the greatest risk of aluminum toxicity. This can lead to bone softening, reduced bone mineralization, microcytic hypochromic anemia, neurological dysfunction, and bile flow reduction or stoppage.
A draft guidance was released by the FDA in December 2022, identifying key factors for measuring an appropriate aluminum limit in products approved for parenteral nutrition. This guidance states that aluminum exposure from parenteral nutrition daily should be less than or equal to 5 mcg/kg.
The FDA has also requested the manufacturer of the unapproved product update the labeling to reflect use is not recommended in pediatric patients because of aluminum toxicity risk. Health care professionals can report adverse events or quality problems with any medicine to the FDA’s MedWatch Adverse Event Reporting program.
Infants atrisk for aluminum toxicity with unapproved potassium phosphates drug product. US Food and Drug Administration. February 9, 2023. Accessed February 13, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/infants-risk-aluminum-toxicity-unapproved-potassium-phosphates-drug-product