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  1. Medical Product Safety Information

Fecal Microbiota for Transplantation: Safety Alert - Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms

[Update Posted 04/07/2020]
[Posted 03/12/2020]

AUDIENCE: Patient, Health Professional

ISSUE: FDA is informing health care providers and patients of the potential risk of serious or life-threatening infections with the use of fecal microbiota for transplantation (FMT).  The FDA is now aware of infections caused by enteropathogenic Escherichia coli (EPEC) and Shigatoxin-producing Escherichia coli (STEC) that have occurred following investigational use of FMT that it suspects are due to transmission of these pathogenic organisms from FMT product supplied by a stool bank company based in the United States.  The stool bank provides FMT product manufactured from pre-screened donors to healthcare providers and researchers.

FDA has been notified of six patients who received the company’s FMT product for Clostridium difficile (also called Clostridioides difficile or C. difficile) infection not responsive to standard therapies and who developed infections caused by EPEC (two patients) or STEC (four patients). Four of the six patients required hospitalization. 

  • The two patients who developed EPEC infection received FMT product that was prepared from stool from two different donors.
  • The four patients who developed STEC infection received FMT product that was prepared from stool from a single donor. 
  • Additionally, the company notified the FDA of two patients who died following receipt of FMT product from the donor associated with the STEC infections. Both patients had chronic medical conditions and received FMT for C. difficile infection. Both patients developed diarrhea after receipt of the FMT product, but their stool was not tested for STEC. These patients died before the four patients with the STEC infections had been reported to either the company or FDA. It is not known if STEC infection contributed to these deaths. 
     

BACKGROUND:  In July 2013, FDA issued a guidance document stating that it intends to exercise enforcement discretion under limited conditions regarding the IND requirements for the use of FMT products to treat C. difficile infection in patients that have not responded to standard therapies.  The guidance states that FDA intends to exercise enforcement discretion provided that the treating physician obtains adequate consent for the use of FMT from the patient or his or her legally authorized representative. The consent should include, at a minimum, a statement that the use of FMT to treat C. difficile is investigational and a discussion of its potential risks.  

RECOMMENDATION:  FDA is informing patients and health care providers of the potential risk of transmission of pathogenic bacteria by FMT products and the resultant serious adverse reactions that may occur. 

  • Patients considering FMT for the treatment of C. difficile infection should speak to their health care provider to understand the associated risks.

Health care providers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online 
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form or submit by fax to 1-800-FDA-0178

[04/06/2020 - Safety Alert - FDA]
[06/18/2019 - Safety Alert - FDA] 

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