The Food and Drug Administration (FDA) issued an Important Safety Alert regarding the use of FMT and risk of serious adverse reactions due to transmission of Multi-Drug Resistant Organisms.
The Alert was issued after two immunocompromised adults received investigational FMT and developed invasive infections caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E.coli); One of the patients lost their lives.
The FMT used were prepared from stool by the same donor but not tested for ESBL-producing gram-negative organisms prior to use. When prepared FMT from the same donor were tested, they were found to be positive for ESBL-producing E. coli identical to the organisms isolated from the two patients.
In July 2013, the FDA issued guidance stating that it intends to exercise enforcement discretion under limited conditions regarding the IND requirements for the use of FMT to treat Clostridium difficile (C. difficile) infection in patients who have not responded to standard therapies. The guidance states that FDA intends to exercise enforcement discretion provided that the treating physician obtains adequate consent for the use of FMT from the patient or his or her legally authorized representative.
Because of these serious adverse reactions that occurred with investigational FMT, FDA has determined that the following protections are needed:
- Donor screening with questions that specifically address risk factors for colonization with 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.