FDA requests market withdrawal of injectable bacitracin
Click Here to Manage Email Alerts
The FDA has requested that manufacturers of the injectable version of bacitracin withdraw their products from the market.
The agency previously approved bacitracin for injection to treat infants with pneumonia and empyema caused by staphylococci, which has been shown to be susceptible to bacitracin, according to an FDA release.
“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, anaphylactic reactions and the need for repeated intramuscular injections,” the FDA said.
“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.”
The FDA said the request does not affect other approved topical or ophthalmic drugs that contain bacitracin.
Reference:
FDA. FDA requests withdrawal of bacitracin for injection from market. https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-bacitracin-injection-market. Accessed January 31, 2020.