FDA Calls for Bacitracin Products to be Removed From the Market

Regulatory NewsRegulatory News
| 31 January 2020 | By Zachary Brennan 

The US Food and Drug Administration (FDA) on Friday requested that all current manufacturers of bacitracin for injection voluntarily withdraw their products from the market.

Bacitracin for injection is currently FDA-approved to treat infants with pneumonia and empyema, which is a collection of pus in the lungs, caused by staphylococci. Manufacturers with bacitracin injections on the market, according to the Orange Book, include Akorn, Fresenius Kabi, Pfizer and Mylan.

But FDA notes the injection’s serious risks, including nephrotoxicity, anaphylactic reactions and the need for repeated intramuscular injections. Last April, the Antimicrobial Drugs Advisory Committee voted almost unanimously, with one abstention, that the risks outweigh the benefits for the drug’s only approved indication.

According to the meeting minutes of that committee, “Of those who voted no, there was consensus on the lack of available data (new and old) to assess safety and efficacy of the drug for this indication. It was further noted that there is no evidence of current use for its labeled indication and a lack of susceptibility criteria (breakpoints) to guide clinicians. Many of those who voted no stated that there are multiple safe and effective alternatives to treat pneumonia and empyema caused by staphylococci in this patient population.”

In its conclusion, FDA said Friday that it “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 Request


© 2022 Regulatory Affairs Professionals Society.

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