The Food and Drug Administration (FDA) has requested that all manufacturers of bacitracin for injection voluntarily withdraw their product from the market.
Bacitracin for injection was approved in 1948 for the treatment of pneumonia and empyema caused by susceptible staphylococci infections in infants. However, the injectable antibiotic has been associated with serious risks, including nephrotoxicity, anaphylactic reactions and the need for repeated intramuscular injections. In 1984, an FDA panel recommended that the treatment be withdrawn due to the unfavorable risk/benefit profile, however no action had been taken following that meeting.
In April 2019, the FDA’s Antimicrobial Drugs Advisory Committee voted almost unanimously, with 1 abstention, that the risks outweigh the benefits for use of bacitracin for injection. In meeting documents, the panel noted that bacitracin for injection was now mostly used off-label as a solution for intraoperative irrigation of surgical wounds.”We did not find any new safety issues with the use of bacitracin irrigation, with the possible exception of medication errors in the surgical setting in which irrigation solutions are inadvertently administered intravenously,” the committee stated.
Current practice guidelines do not include bacitracin for injection as an option for community-acquired pneumonia in infants and children. Given the availability of other effective and safer FDA-approved treatments, the Agency determined that it was necessary to remove the drug from the market to reduce the potential for harm.
This requested voluntary withdrawal does not affect the topical or ophthalmic formulations of bacitracin.
Any adverse events associated with the use of any medication should be reported to the FDA’s MedWatch program.
For more information visit fda.gov.