Regulatory Focus™ > News Articles > 2019 > 6 > FDA Warns of One Death Linked to Fecal Transplants

FDA Warns of One Death Linked to Fecal Transplants

Posted 13 June 2019 | By Zachary Brennan 

FDA Warns of One Death Linked to Fecal Transplants

The US Food and Drug Administration (FDA) on Thursday warned medical and scientific communities and other interested persons of the potential risk of transmitting multi-drug resistant organisms (MDROs) via poop transplants, otherwise known as fecal microbiota for transplantation (FMT).

FMT is typically used to help patients with the bacterium Clostridium difficile who are not responding to standard therapies. 2013 guidance from FDA revealed that the agency 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. The consent should include, at a minimum, a statement that the use of FMT to treat C. difficile is investigational and a discussion of its potential risks. 
“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 agency said Thursday.
The FMT used in these two individuals were prepared from a stool obtained from the same donor, although neither the donor stool nor the resulting FMT was tested for ESBL-producing gram-negative organisms prior to use.
“After these adverse events occurred, stored preparations of FMT from this stool donor were tested and found to be positive for ESBL-producing E. coli identical to the organisms isolated from the two patients,” FDA said.

Openbiome, a nonprofit stool bank based in Cambridge, MA, told Focus: "We are saddened to hear of the recent patient death due to an infection from a multi-drug resistant organism (MDRO) transmitted through a fecal transplant. OpenBiome material was not involved. OpenBiome screens its donors and fecal transplant material for MDROs and related risk factors, and this serious event further highlights the importance of rigorous screening and clinical oversight for all fecal transplant procedures." 
Moving forward, FDA unveiled two new protections necessary for any investigational use of FMT:
  • “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.”
Safety Alert


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.