The FDA requested all drugmakers that make bacitracin for injection — a drug to treat infants with pneumonia and empyema — to pull it from the market, saying the risks associated with the drug outweigh the benefits.
Drugmakers that have bacitracin injections on the market include Pfizer, Mylan, Akorn and Fresenius Kabi, according to Regulatory Focus.
The FDA said the drug has serious risks, including kidney damage, severe allergic reactions and the need for repeated intramuscular injections.
The FDA's antimicrobial drugs advisory committee voted last April, almost unanimously, that the risks outweigh the benefits for bacitracin injections, Regulatory Focus reported. The committee also said there are multiple safe and effective alternatives to treat pneumonia and empyema.
The FDA said Jan. 31 that it "believes that the potential problems associated with bacitracin for injection are sufficiently serious to remove the drug from the market."
Read the full news release here.