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Update to March 12, 2020 Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms

March 13, 2020

On March 12, 2020, the Food and Drug Administration (FDA) informed 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 agency 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 received and evaluated new information that was submitted by the stool bank pertaining to the two deaths previously described in the Safety Alert. Both patients had chronic medical conditions and received FMT for treatment of recurrent C. difficile infection. For one of the patients who died and was not tested for STEC, the retained sample of the stool used to manufacture the FMT product that was administered was tested using a nucleic acid test and found to be positive for STEC. For this patient, it is still not known if STEC infection contributed to their death. For the other patient who died and was not tested for STEC, the retained sample of the stool used to manufacture the FMT product that was administered was tested using a nucleic acid test and found to be negative for STEC. With this new information, FDA does not suspect that STEC was transmitted by this FMT product to this patient.

 

FDA Safety Alert Regarding the Use of Fecal Microbiota for Transplantation and Risk of Serious Adverse Events Likely due to Transmission of Pathogenic Organisms – March 12, 2020