FDA: Avoid Unapproved Potassium Phosphates Injection in Pediatric Patients

The Food and Drug Administration (FDA) has issued a safety alert regarding the use of unapproved potassium phosphates drug products in pediatric patients, specifically those manufactured by Hospira.

Potassium phosphates injection is a phosphorus replacement product indicated as a source of phosphorus in intravenous fluid to correct hypophosphatemia and for parenteral nutrition. In pediatric patients, use of Hospira's potassium phosphates drug product may result in daily aluminum exposures of up to twice the recommended limit for parenteral nutrition.

According to the FDA, the total allowable aluminum exposure from parenteral nutrition should not exceed 5mcg/kg/day. Exposure to toxic levels of aluminum can result in osteomalacia, reduced bone mineralization, neurological dysfunction, microcytic hypochromic anemia, and cholestasis.

Products with an aluminum content level considered acceptable for each patient based on age, weight, and recommended dose of phosphorus include Fresenius Kabi's Potassium Phosphates Injection and CMP Development's Potassium Phosphates Injection.

The FDA has requested that Hospira update the labeling for its potassium phosphates product to state that it is not recommended in pediatric patients because of aluminum toxicity.

Reference

US Food and Drug Administration. Infants at risk for aluminum toxicity with unapproved potassium phosphates drug product. Accessed February 9, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/infants-risk-aluminum-toxicity-unapproved-potassium-phosphates-drug-product.