FDA AMDAC (26 April 2019) on IM Bacitracin for pneumonia in infants: Follow-up note

Addendum: This is the third in a series of newsletters on IM bacitracin. Go here for the prior newsletter and here for the 4th and final newsletter.

Aside: I can’t comment on it in detail today, but do note that IACG (Interagency Coordination Group on AMR) have just released their final report to the UN Secretary General (link). IACG recommend continued work at the country level, support for sustainable responses (including innovation), and enhanced global governance/accountability.

Dear All:

I wrote previously with a heads-up on the 26 Apr 2019 FDA AMDAC on IM bacitracin as a therapy for pneumonia and empyema in infants. The initial note (25 Apr 2019, link) summarized the FR announcement and the follow-up note (1 Apr 2019, link) reflected on responses I’d received from the pediatric community (“IM Bacitracin? Never used it!”) and the veterinary community (“It’s an important product for treating necrotic enteritis in poultry!”).

The AMDAC has now come and gone and with the help of Jeff Watts (Research Director for Anti-Infectives at Zoetis), I offer this brief summary of its outcomes.

Key data points from the day:

  • Bacitracin was originally registered by The Upjohn Company in 1948.
  • Due to its toxicity, IM bacitracin’s use gradually declined, and an FDA advisory committee recommended withdrawal of the approval in 1984.
  • The approval was not withdrawn, but available data suggest it has not been used for the IM indication in over 40 years.
  • Rather, it is main use is as wound or surgical irrigation in adults.

After the presentations and discussion, the AC voted 0-17-1 (yes-no-abstain) in response to the question “Do the benefits of bacitracin for intramuscular injection outweigh the risks for its approved indication of the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug?” The one abstention was on the “theoretical grounds of dire need.” Comments on the vote focused on the ready availability of less toxic alternative agents.

A reasonable guess at this point would be that FDA will either withdraw the approval or add further restrictions on use to the label. Bacitracin is an important agent to veterinary medicine for the treatment of necrotic enteritis in poultry. This outcome will allow for veterinarians to continue to prescribe bacitracin in lieu of more medically important agents such as lincosamides (lincomycin) or macrolides (tylosin).


All best wishes (and with thanks to Jeff for helping create this summary), –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: http://amr.solutions/blog/

Upcoming meetings of interest to the AMR community:

  • 6-11 May 2019 (Ljubljana, Slovenia): 37th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). Details here.
  • 20 May 2019 (everywhere): Application deadline for NIAID solicitation (HHS-NIH-NIAID-BAA2019-1) for proposals to support new vaccine or therapeutics candidates targeting antibiotic-resistant bacterial infections. Go here for more details.
  • 3-6 Jun 2019 (Philadelphia): Annual BIO meeting
  • 20-24 June 2019 (San Francisco): Annual ASM Microbe meeting.
  • 10-11 Jul 2019 (Madison, WI): Tiny Earth Symposium, a teaching consortium that uses crowd-sourcing of antibiotic-producing microbes to improve undergraduate education. Details here.
  • 12 July 2019 (FDA, White Oak Campus): Public workshop to discuss the 2018 LPAD guidance. Register here.
  • [Mark your calendar now!] 3-6 Sep 2019 (Boston). Annual ASM-ESCMID Conference on Antibiotic Development. The Bootcamp series will continue on 3 Sep with main meeting on 4-6 Sep. Mark your calendar now and check back here for details.
  • 6-8 Sep 2019 (Bilbao, Spain): 5th ESCMID conference on Vaccines. Check back here for details.
  • 2-6 Oct 2019 (Washington, DC): IDSA’s annual IDWeek meeting.
  • 19-27 Oct 2019 (Annecy, France): International Course on Antibiotics and Resistance (ICARe) – A soup-to-nuts intensive residential training program on all things AMR, especially R&D for new antibiotics. See this link for details.
  • [Mark your calendar now!] 1-6 Mar 2020 (Il Ciocco, Tuscany, Italy): GRC on Antibacterial Discovery and Development: “Now is the time to re-boot antibiotic R&D before it’s too little, too late.” Not yet online, but the date is firm. Will share a link when it becomes available.
  • 12-13 Mar 2020 (Berlin?): BEAM-, Novo REPAIR-, CARB-X-, DZIF-, ND4BB-, ENABLE-supported (among a long list!) Conference on Novel Antimicrobials and AMR Diagnostics. Final location is TBD, details will appear here, and you should mark your calendar now. 
  • 18-21 Apr 2020 (Paris): Annual ECCMID meeting (#30)
  • 10-13 Apr 2021 (Vienna): Annual ECCMID meeting (#31)


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