The FDA warned healthcare workers and pharmacies on Feb. 9 not to use an unapproved potassium phosphates drug made by Hospira, a Pfizer company, in pediatric patients because the aluminum exposure can be up to double the agency's limit.
Toxic exposure levels to aluminum can cause softening of the bones, reduced bone mineralization, neurological problems, microcytic hypochromic anemia, and a lessened or stopped bile flow, according to the regulatory agency.
Potassium phosphates injections are used in IV fluids "to correct hypophosphatemia and for parenteral nutrition in adults and pediatric patients," the FDA said.
The alert recommended two FDA-approved drugs: Fresenius Kabi's potassium phosphates drug for all ages, and CMP Development's injection for patients 12 and older who weigh at least 88 pounds and adults who weigh at least 99 pounds.