FDA Issues Warning Against Fecal Transplants After Patient Death

The U.S. Food and Drug Administration has issued a warning against fecal transplant procedures after a patient death was attributed to the treatment. The patient reportedly received a fecal transplant containing drug-resistant bacteria and succumbed to the infection soon after. As a result, the FDA is now requiring that potential donors be screened with questions and all donor stool be tested for drug-resistant bacteria.

The FDA warning says that fecal transplants can lead to serious or life-threatening infections. The idea behind the procedure is to use a processed version of stool from a healthy person to transfer good bacteria to the intestines of an infected person. The bacteria found in the healthy stool repopulate the colon of the patient to crowd out the infectious bacteria.

In the case that sparked the warning, two adults with comprised immune systems who received a transplant from the same donor developed invasive infections caused by Escherichia coli (E.coli). After the patients got sick, a stored sample from the donor was tested and found to contain the E. coli present in the two patients. According to the FDA statement, the donor stool was not tested for the drug-resistant bacteria prior to the procedure.

The FDA statement does not specify why the patients received the fecal transplants. However, fecal transplants have started being used increasingly to treat intestinal disorders, including cases of Clostridium difficile, or C. diff, that haven’t responded to antibiotics. According to the Centers for Disease Control and Prevention, C. diff infections kill 29,000 Americans a year and make 450,000 sick. The fecal transplant treatment for C. diff hasn’t yet been approved by the FDA.