Bacitracin for Injection Market Withdrawal

Updated: Jun 3, 2020

Bacitracin for Injection

Reason for the Shortage

· FDA requested that all manufacturers of bacitracin for injection voluntarily withdraw their product from the market. More information is available at the following link: https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-bacitracin-injection-market

Estimated Resupply Dates

· FDA requested that all manufacturers of bacitracin for injection voluntarily withdraw their product from the market. More information is available at the following link: https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-bacitracin-injection-market. All products will be discontinued.

Implications for Patient Care

· 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.

· The product is most frequently used for intraoperative irrigation of surgical wounds. FDA published a report in April 2019 that describes the evidence for use of bacitracin irrigations, as well as information about adverse reactions. The report can be found at the following link: https://www.fda.gov/media/123641/download

· The guidelines for antimicrobial prophylaxis in surgery developed by the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, the Surgical Infection Society, and the Society for Healthcare Epidemiology of America do not support the use of antimicrobial irrigation solutions due to lack of evidence demonstrating additional benefits over use of intravenous antimicrobial prophylaxis alone.[1]

Products Affected - Description

· Baciim intramuscular powder for solution for injection, X-Gen, 5000 units, vial, 10 count, NDC 39822-0277-02 - discontinued

· Bacitracin intramuscular powder for solution for injection, Fresenius Kabi, 5000 units, vial, 10 count, NDC 63323-0329-31 - discontinued

· Bacitracin intramuscular powder for solution for injection, Fresenius Kabi, 5000 units, vial, NDC 63323-0329-30 - discontinued

· Bacitracin intramuscular powder for solution for injection, Pfizer, 5000 units, vial, 10 count, NDC 00009-0233-03 - discontinued

· Bacitracin intramuscular powder for solution for injection, Pfizer, 5000 units, vial, NDC 00009-0233-01 - discontinued

· Bacitracin intramuscular powder for solution for injection, Xellia Pharmaceuticals, 5000 units, vial, 10 count, NDC 70594-0026-02 - discontinued

References

·

1. Bratzler, D.W., et al., Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm, 2013. 70(3): p. 195-283.

2.  https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-bacitracin-injection-market

3.  https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=631

4.  https://www.drugtopics.com/latest/fda-requests-withdrawal-bacitracin-injection-market


23 views0 comments