FDA Warns on Use of Hospira Drug in Kids Due to ‘Unsafe’ Aluminum Levels

Healthcare workers and pharmacies should stop using unapproved potassium phosphates drug products from Hospira in pediatric patients due to unsafe levels of aluminum, the FDA warned on Thursday.

Providers should instead turn to approved options indicated for pediatric patients, the agency recommended.

Potassium phosphates drug products are used in intravenous fluids, usually to replace phosphorus for patients with hypophosphatemia and for adults and children getting parenteral nutrition. Those on long-term parenteral nutritional support have the highest risk for aluminum toxicity, which can cause osteomalacia, neurological issues, and cholestasis, along with reduced bone mineralization and microcytic hypochromic anemia, according to the FDA.

Hospira’s 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,” the agency said in its warning.

FDA requested that the sponsor of the unapproved product (parent company Pfizer), “revise its labeling to reflect that use of the product in pediatric patients is not recommended because of the risk of aluminum toxicity.”

The agency recommended using approved potassium phosphates injection products with “aluminum content level considered acceptable” for patients based on age, weight, and dosing. These include:

• Fresenius Kabi’s product for all ages
• CMP Pharma’s product for pediatric patients 12 and up weighing at least 88 lb and adults weighing at least 99 lb

New guidance from the FDA recommends that patients with renal impairment, including preterm infants, are exposed to no more than 5 mcg/kg of aluminum per day.

Parenteral drug or pharmacy bulk packages can become contaminated with aluminum “in raw materials as well as through byproducts from the manufacturing process and packaging system, during which aluminum may leach from the manufacturing equipment and/or container closure components (e.g., glass vials, stoppers) during autoclave terminal sterilization and shelf-life storage,” according to the new guidance document.