FDA Requests Withdrawal of Bacitracin Injection from Market

February 3, 2020

The FDA is requesting that manufacturers of bacitracin for injection voluntarily withdraw their product. 

Officials with the FDA are calling for manufacturers of bacitracin for injection to voluntarily withdraw their product from the market, according to a drug safety communication.1

According to the drug safety communication, which was issued on January 31, 2020, the requested voluntary withdrawal does not affect topical or ophthalmic drugs that contain bacitracin.

Bacitracin for injection was initially approved by the FDA to treat infants with pneumonia and empyema caused by staphylococci, a type of bacteria, shown to be susceptible to the drug. However, health care professionals no longer use bacitracin for injection due to other effective FDA-approved treatments that are available that do not carry the same serious risks. Bacitracin for injection is associated with increased risks of nephrotoxicity, anaphylactic reaction, and the need for repeated intramuscular injections.

Based on the FDA’s review of currently available data, the agency determined that the potential problems associated with bacitracin for injection are sufficiently serious to remove the drug from the market.

According to the FDA, the majority (97-98%) of patients who received bacitracin for injection from 2015 through 2018 were 17 years of age and older, suggesting very limited use in infants. There were no data that bacitracin for injection is currently used for its labeled indication.2

At a Antimicrobial Drugs Advisory Committee meeting held in April 2019, committee members voted almost unanimously that the risks outweigh the benefits for bacitracin for injection’s only approved indication. There was 1 abstention.

The 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.

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