On June 13, 2019, the FDA issued a warning about the risk of transmitting multidrug resistant organisms (MRDOs) via fecal microbiota transplant (FMT). Two immunocompromised individuals who received FMT were infected with Escherichia coli (E coli) expressing extended-spectrum beta-lactamase (ESBL). One of the infections was fatal. The stool used to prepare FMT for both individuals was from a single donor. Neither FMT sample was tested for ESBL prior to administration. After the infections were detected, other stored FMT samples from the same donor tested positive for ESBL-producing E coli identical to isolates from the two patients.
Fecal microbiota transplant is considered an investigational treatment for resistant Clostridium difficile (C difficile) infection. The FDA exercises enforcement discretion for FMT, allowing use by providers who obtain consent from the patient or an authorized legal representative. Consent must include discussion of the investigational nature of FMT and its potential risks. In response to these ESBL-producing E coli infections, FDA now requires that donors are screened for risk factors associated with MDRO colonization and donor stool is screened for the presences of MDROs. Stool that tests positive for MDROs or is from donors at high risk of MDRO colonization must not be used for FMT. Suspected adverse events associated with FMT should be reported to the FDA MedWatch Program: http://www.fda.gov/medwatch.
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