The US Food and Drug Administration (FDA) has sounded a warning over the use of faecal microbiota transplantation (FMT) and the risk of serious or life-threatening infections due to transmission of multi-drug resistant organisms (MDROs), following the death of a patient who had received investigational FMT.
In a new safety alert, the agency reports that two immunocompromised adults who had received investigational FMT developed invasive infections caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E.coli). One of these patients died.
According to the FDA, FMT in these two individuals used samples from the same donor and stool. Testing for ESBL-producing gram-negative organisms was not performed prior to use. It said subsequent testing of preparations of FMT from this stool donor were found to be positive for ESBL-producing E. coli identical to the organisms isolated from the two patients.
The FDA has recommended precautions for the investigational use of FMT, including exclusion of donors at higher risk of colonisation with MDROs and exclusion of stool that tests positive for MDRO.