WASHINGTON -- Infections with antibiotic-resistant organisms have resulted from fecal microbiota transplants (FMT) -- at least one fatal -- and patients and clinicians should be aware of the risk, the FDA said Thursday.
"Two immunocompromised adults who received investigational FMT developed invasive infections caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E. coli). One of the individuals died," the .
Stool from a single donor was used for both procedures, the FDA said, and had not been tested for ESBL-producing organisms. Subsequent testing of stored samples from this donor confirmed the presence of ESBL-producing E. coli.
FMT has increasingly been used for treating refractory Clostridium difficile infections, with researchers also investigating the procedure for other conditions such as irritable bowel syndrome.
In 2013, the agency said it would use "enforcement discretion" to keep a relatively light regulatory hand on FMT research. In a , the FDA indicated that it would only ask investigators to discuss potential risks of the procedure as a C. difficile treatment and obtain informed consent. Patients should particularly be told that FMT is investigational.
Now, following these serious adverse events, the FDA said it would impose new restrictions.
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 MDROs [multi-drug resistant organisms], 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."
Patients should still be advised that FMT is investigational. Any healthcare provider using FMT in patients should also report adverse events to the FDA, the agency said.