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Injectable Bacitracin’s Lone Indication Should Be Revoked, US FDA Panel Says

Executive Summary

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.

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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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Widespread Off-Label Use Could Ensure Injectable Bacitracin's Future

US FDA advisory committee will weigh fate of the injectable antibiotic, which can cause renal failure and is only approved for treatment of pediatric pneumonia. However, its real-world use is almost entirely in the surgical setting for irrigation and prophylaxis. Xellia, one of five companies that markets the generic drug, said the risk/benefit profile for on-label use remains positive and evidence on off-label use warrants further exploration.

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