Two adults with weakened immune systems who received investigational fecal microbiota transplantations developed invasive infections caused by extended-spectrum beta-lactamase-producing Escherichia coli, according to an FDA press release.
One of those individuals subsequently died.
As a result, the FDA issued a safety alert on Thursday to inform health care providers and patients of the possible risks for contracting serious infections when using FMT.
The FMT conducted in the two patients was prepared from stool obtained from the same donor, according to the release. However, according to the release, the donor stool was not tested for extended-spectrum beta-lactamase (ESBL) -producing gram-negative organisms prior to transplant.
Following transplant and the occurrence of the severe adverse events, the donor stool was tested and found to be positive for ESBL-producing E. coli identical to the organisms isolated from the two patients.
Although FMT has been shown to be safe in individuals who are obese, as well as safe and effective in children and adults with Clostridioides difficile infection, it is not an FDA-approved treatment.
Because of these two infections and subsequent death, the FDA has issued added safety requirements for any investigational use of FMT.
Donor stool must be screened for colonization with multi-drug resistant organisms (MDROs) and individuals at higher risk for colonization with MRDOs should be excluded from any FMT use.
If a donor stool tests positive for an MDRO it should be removed from future use, according to the release.
Rebiotix, a clinical-stage microbiome company that develops microbiota restoration therapies for the treatment of gastrointestinal diseases, said in a statement sent to Healio Gastroenterology and Liver Disease that the company supports stringent screening of donor stool for FMT use.
“We have always been a strong proponent of having appropriately screened donor derived microbiota products to avoid a public health problem as described in the FDA safety alert,” the statement said. “We were the first company to engage the FDA in defining a regulatory pathway for microbiota-based therapies and remain committed to working closely with the agency to continue to conduct high-quality clinical trials and stringent donor screening programs.” – by Ryan McDonald