Recently on their agency's website2, the United States Food and Drug Administration (FDA) issued a safety alert for fecal transplant procedures. This announcement comes after two immunocompromised patients contracted an invasive infection of a drug-resistant Escherichia coli following a fecal material transplantation. The FMT donor material was not tested for this pathogen. As a result, the agency is planning to suspend multiple clinical trials involving this procedure.
Furthermore, due to the serious adverse reactions that occurred within this FMT clinical trial, the FDA has determined that the following protections are needed for any investigational use of FMT:
- Donor screening with questions that specifically address risk factors for colonization with multi-drug resistant organisms (MDROs), and exclusion of individuals at higher risk of colonization with MDROs.
- MDRO testing of donor stool and exclusion of stool that tests positive for MDRO. FDA scientists have determined the specific MDRO testing and frequency that should be implemented.
It remains to be seen how this safety alert will ultimately impact the future use of FMT to treat diseases. Once hailed as a relatively low-cost and simple therapy, this recent unfortunate news has revealed new risks that need to be accounted for. Pending additional guidance, it seems likely that higher stringency testing requirements will likely be needed as a measure to prevent future severe adverse events.