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FDA Warns After Fecal Transplant Proves Fatal


The FDA has issued a safety alert regarding the use of fecal microbiota for transplantation, or FMT, following reports of two adults who received the investigational FMT developing invasive infections caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E.coli).

What is fecal microbiota transplantation?

Fecal microbiota transplantation involves taking stool from a healthy person, diluting it with water and transferring it into the patient's intestine. There are a number of ways to perform this procedure like nasogastric tube, nasojejunal tube, upper tract endoscopy, colonoscopy or retention enema.

Though not FDA-approved, FMT has been used for the treatment of recurrent Clostridium difficile Infection, a complication of antibiotic therapy.

The two adults with a weakened immune system were treated with FMT, using stool obtained from the same donor. The donor stool was not tested for the extended-spectrum beta-lactamase (ESBL)-producing gram-negative organisms prior to use.

While the two patients developed invasive infections, it proved fatal for one of them.

Upon testing the stored preparations of FMT from the stool donor, they were found to be positive for ESBL-producing E. coli, identical to the organisms isolated from the two patients.

ESBL-producing E.coli are antibiotic-resistant strains of E.coli, and they cause a wide range of infections, say diarrhea, pneumonia, urinary tract infections and even sepsis (severe blood poisoning).

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