Fecal microbiota for transplantation or more commonly known as fecal transplant, shows promise in helping to treat various conditions. Now, however, the U.S. Food and Drugs Administration is warning of the risks after a patient’s death was found to be related to the procedure.
On June 13, the FDA released a public safety alert regarding the use of FMT after two people who underwent the procedure developed invasive infections that came from the same donor.
Evidently, the donor’s stool was not tested for Escherichia coli (E.coli) before the procedure, and hence the drug-resistant bacteria was passed onto the two patients who happened to be immuno-compromised. It was after the two patients developed the infections that the donor’s stool was tested and found to be positive for the same strain of drug-resistant E.coli infecting the patients.
Unfortunately, one of the patients eventually died.
So far, fecal transplants are considered experimental treatments for Clostridium difficle, a life-threatening infection that causes severe diarrhea. Basically, the idea for the procedure is to balance out the gut bacteria of a patient by transplanting fecal matter from a healthy donor and transplanting it into the patient’s colon.
“In July 2013, FDA issued guidance stating that it intends to exercise enforcement discretion under limited conditions regarding the IND requirements for the use of FMT to treat Clostridium difficile (C. difficile) infection in patients who have not responded to standard therapies,” the FDA said in the statement regarding the recent incident.
In the guidance, treating physicians must obtain consent from a patient or legal representative, informing them, at least, that the treatment is still investigational, as well as of the potential risks involved.
Because of the incident that caused the death of a patient, the FDA now requires donor screening and testing for multi drug-resistant organisms, excluding potential donors with higher risks of MDRO colonization and those who test positive for it.
Patients who are interested in having FMT are also advised to talk to their healthcare provider to fully understand the potential risks involved in undergoing the treatment.