Pharmacy Services Alerts
Fecal Microbiota Transplant (FMT) and Risk of Pathogenic Organism Transmission
Mar 13, 2020 11:27 AM
On March 12, 2020, the FDA issued a warning about the potential risk of transmission of pathogenic bacteria by FMT products. Fecal microbiota transplant is considered an investigational treatment for resistant Clostridium difficile (C difficile) infection. Six patients who received FMT from a stool bank company based in the United States developed infections. Two cases were caused by enteropathogenic Escherichia coli (EPEC) from 2 different donors. Four were from Shigatoxin-producing Escherichia coli (STEC) from 1 donor. Four of these 6 patients required hospitalization. Two additional patients died who also received FMT for C difficile from the donor associated with the STEC infections. It is not known if STEC infection contributed to their deaths, as both patients had chronic medical conditions and their stool was not tested for STEC.
Health care providers and patients are being informed by the FDA of the potential risk of adverse events secondary to pathogenic bacterial transmission via FMT. On June 13, 2019, the FDA issued a similar warning regarding the risk of transmitting multidrug resistant organisms (MDROs) via FMT. Patients considering FMT for C difficile should discuss the associated risks with their health care provider. Report suspected adverse events associated with FMT to the FDA MedWatch Program: www.fda.gov/medwatch.
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