[1/31/2020] The U.S. Food and Drug Administration has requested that all current manufacturers of bacitracin for injection voluntarily withdraw their product from the market. Bacitracin for injection is currently FDA-approved to treat infants with pneumonia and empyema (a collection of pus in the space between the membranes lining the lungs) caused by staphylococci, a type of bacteria, shown to be susceptible to the drug. However, health care professionals no longer use bacitracin for injection to treat this condition because other effective FDA-approved treatments are available that do not have the same serious risks, including nephrotoxicity (harm to the kidneys), anaphylactic reactions and the need for repeated intramuscular injections.
In April 2019, the Antimicrobial Drugs Advisory Committee met and discussed the safety and effectiveness of bacitracin for injection. The advisory committee voted almost unanimously, with one abstention, that the risks outweigh the benefits for the drug’s only approved indication.
Based on FDA’s review of currently available data, FDA believes that the potential problems associated with bacitracin for injection are sufficiently serious to remove the drug from the market.
This requested voluntary withdrawal does not impact approved topical or ophthalmic drugs that contain bacitracin.
FDA encourages health care professionals and patients to report adverse events with the use of any medication to FDA’s MedWatch Adverse Event Reporting Program:
- Complete and submit the report online; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178