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# Fecal Microbiota for Transplant Safety Alert
- URL: https://www.fdaweb.com/fecal-microbiota-for-transplant-safety-alert/
- Published: 2020-03-12T12:00:00.000Z
- Updated: 2026-09-14T16:06:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146315

FDA is alerting healthcare providers and patients to the potential risk of serious or life-threatening infections with the use of fecal microbiota for transplantation (FMT). An agency [notice](https://www.regulations.gov/contentStreamer?documentId=FDA-2020-P-1065-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says it is aware of infections caused by enteropathogenic *Escherichia coli* and Shigatoxin-producing *Escherichia coli* that have occurred following investigational use of fecal microbiota for transplantation. FDA says it suspects the infections are due to transmission of the pathogenic organisms from FMT products supplied by a stool bank company based in the U.S.

The notice says that a 7/2013 guidance indicated the agency would exercise enforcement discretion under limited conditions regarding the IND requirements for using FMT products to treat *C. difficile* infections in patients that have not responded to standard therapies. The guidance said that enforcement discretion would be exercised provided the treating doctor obtains adequate consent for the use of FMT from the patient or authorized representative.

The agency says patients considering FMT to treat *C. difficile* infection should talk with their healthcare provider about the associated risks.