In an update to a warning issued last year, the FDA said Wednesday it remains concerned about the risk of aluminum toxicity associated with a Pfizer subsidiary’s unapproved potassium phosphate injection for children.
Hospira, which Pfizer bought in 2015 for $17 billion, agreed on Aug. 1 to stop distributing unapproved potassium product within 90 days, according to the regulator.
“However, some of the Hospira product may remain in hospital pharmacies until the supply is used up,” the FDA cautioned. The agency also said that hospitals can use generic versions of the drug “with acceptable aluminum levels for pediatric patients” that have been approved since February 2023.
Pfizer did not immediately respond to a request for comment.
In early 2023, the FDA warned hospitals that Pfizer’s product “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.”
At the time, the agency directed healthcare providers to Fresenius Kabi’s potassium phosphate injections as an alternative.