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One person died after receiving a stool transplant containing a drug-resistant bacteria, the Food and Drug Administration announced Thursday.
The FDA warns 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 a weakened immune system who received the FMT from the same donor developed serious infections, the FDA said. A patient is dead.
The FDA noted that the donor's stool had not been tested before transplanting for the drug-resistant bacterium, called E. coli producing extended-spectrum beta-lactamase (ESBL). After illness and death, however, a stored stool preparation of the donor was tested and found to be positive for the same bacterial strain found in both patients.
The FDA statement does not specify why patients received fecal transplants. However, this procedure is commonly used to treat a difficult to treat bacterial infection called C. difficile.
According to the Centers for Disease Control and Prevention, C. diff infections kills 29,000 Americans a year and makes 450,000 sufferers in the United States alone.
The treatment consists of obtaining stool from a healthy donor and transplanting a transformed version of these stool into the patient. The collection of bacteria in healthy stools – called microbiota – repopulates the patient's colon and essentially crowds out the infectious bacteria.
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