FDA Safety Alert: Infants at Risk for Aluminum Toxicity with This Unapproved Drug Product
Audience: Consumers
February 9, 2023 — FDA is warning healthcare professionals and pharmacies to avoid using Hospira’s unapproved potassium phosphates drug product in pediatric patients because the aluminum exposure from this product is unsafe for this population.
This product alone may produce daily aluminum exposures of up to twice the FDA-recommended limit for parenteral nutrition, with additional aluminum exposure expected from the other components of parenteral nutrition.
FDA recommends health care 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.
- FDA considers Fresenius Kabi’s product appropriate for patients of all ages.
- FDA considers CMP Development’s product is appropriate for pediatric patients 12 years of age and older who weigh at least 40 kg and adults weighing at least 45 kg.
These FDA-approved products provide detailed dosing instructions for preparation and administration to minimize the risk of aluminum toxicity.
The potassium phosphates injections are phosphorus replacement products intended for use as a source of phosphorus in IV fluids to correct hypophosphatemia and for parenteral nutrition in adults and pediatric patients. Patients on prolonged courses of parenteral nutrition support are at the greatest risk of exposure to toxic levels of aluminum. Exposure to toxic levels of aluminum can lead to softening of the bones (osteomalacia), reduced bone mineralization, neurological dysfunction, microcytic hypochromic anemia, and reduction or stoppage of bile flow (cholestasis).
In December 2022, FDA issued a draft guidance for industry that clarifies the key factors in determining the appropriate aluminum limit in a small-volume parenteral drug or pharmacy bulk package for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. FDA’s guidance includes a recommendation that the total allowable aluminum exposure from parenteral nutrition should not exceed 5 mcg/kg/day.
FDA has requested that the unapproved product sponsor manufacturer revise its labeling to reflect that use of the product in pediatric patients is not recommended because of the risk of aluminum toxicity. Learn more about unapproved marketed drug products on FDA’s Unapproved Drugs page.
FDA encourages health care professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at Medwatch; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Source: FDA
