FDA Issues Warning as Patient Dies after Receiving Fecal Microbiota Transplantation

Taking a cue from two cases whereby one immunocompromised patient died and second became infected after receiving fecal microbiota transplantation (FMT), the FDA issued a safety warning about the potential risk associated with the use of fecal microbiota for transplantation (FMT). The FMT preparations contained extended-spectrum β-lactamase (ESBL)-producing Escherichia coli.

The agency is now aware of bacterial infections caused by multi-drug resistant organisms (MDROs) that have occurred due to the transmission of an MDRO from use of investigational FMT.

FMT used in these two individuals were prepared from stool obtained from the same donor. The donor stool and resulting FMT used in these two individuals were not 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.

Fecal microbiota transplant, also known as a stool transplant, is the process of transplantation of fecal bacteria from a healthy individual into a recipient. It involves the restoration of the colonic microflora through the introduction of healthy bacterial flora by infusing stool. Its effectiveness has been established in clinical trials for the treatment of Clostridioides difficile infection (CDI), that can result in diarrhea, pseudomembranous colitis.

According to guidance issued in 2013, the FDA considers FMT to be an investigational new drug that clinicians can use to treat Clostridium difficile infection in patients unresponsive to standard therapies. FMT has also been studied in irritable bowel syndrome and ulcerative colitis.

• Patients considering FMT to treat C. difficile infection should speak to their health care provider to understand the potential risks associated with the product’s use.


• Healthcare providers must obtain 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.


• Because of these serious adverse reactions that occurred with investigational FMT, 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, 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.
  
  
  
  


• Healthcare professionals and patients should be encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.