An FDA advisory committee Friday voted 17-1 with one abstention that the injected form of the antibiotic bacitracin is of no value for its sole approved indication, but committee members called for more research on a common off-label use of the drug.
Intramuscular (IM) injection bacitracin is approved only for infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug.
The Antimicrobial Drugs Advisory Committee members heard evidence that the drug has not been used for this purpose in decades, but that it is widely used in the surgical setting for wound irrigation.
Asked to vote on whether the benefits of bacitracin for intramuscular injection outweigh the risks for its approved indication, 17 committee members voted ‘no,’ none of the members voted ‘yes,’ and chairman Lindsey R. Baden, MD, abstained.
