US FDA Seeks Withdrawal Of Injectable Bacitracin Despite Extensive Off-Label Use
Injectable bacitracin, often used as a surgical irrigant, carries serious risks of nephrotoxicity and anaphylaxis; product is no longer prescribed for its lone approved indication in pediatric pneumonia. FDA’s decision aligns with advisory committee recommendations in 1984 and 2019.
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Although advisory committee members call for new studies to support the antibiotic’s extensive off-label use in surgical irrigation, they point to financial and practical hurdles to obtaining such data.