Fecal Microbiota for Transplantation

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

A MedWatch Safety Alert was added to the FDA [MedWatch, Recalls, Medical Device Recalls or Medical Devices] webpage.  TOPIC: Fecal Microbiota for Transplantation: Safety Alert - Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms 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.