One person has died after receiving a fecal transplant containing drug-resistant bacteria, the Food and Drug Administration announced Thursday.
The FDA is warning health care providers that the use of the so-called fecal microbiota for transplantation (FMT) can lead to serious or life-threatening infections.
Two patients with weakened immune systems who received FMT from the same donor developed serious infections, the FDA said. One patient died.
The FDA noted that the donor stool had not been tested for the drug-resistant bacteria, called extended-spectrum beta-lactamase (ESBL)-producing E. coli, prior to the transplantation. After the illnesses and death occurred, however, a stored preparation of the donor stool was tested, and found to be positive for the identical strain of bacteria found in the two patients.
The FDA statement does not specify why the patients received the fecal transplants. However, the procedure is commonly used to treat a difficult-to-treat bacterial infection called C. difficile.
C. diff infections kill 29,000 Americans a year and make 450,000 sick in the United States alone, according to the Centers for Disease Control and Prevention.
The treatment involves obtaining stool from a healthy donor, and transplanting a processed version of that stool into the patient. The collection of bacteria found in the healthy stool — called the microbiota — repopulate the colon of the patient, and essentially crowd out the infectious bacteria.
Sara G. Miller is the health editor for NBC News, Health & Medical Unit. She was previously the health editor at LiveScience.com.