Published: Mon, June 17, 2019
Health Care | By Cedric Leonard

Patient Dead From Superbug Infection After Fecal Transplant, FDA Warns

Patient Dead From Superbug Infection After Fecal Transplant, FDA Warns

FMT, which involves transplanting stool from a healthy person into the colon of a sick person, is still not approved by the FDA.

The FDA is warning against possible complications from faecal transplants after one person died and another was sickened.

According to the FDA, 2 immunocompromised individuals who received the investigational FMT developed invasive infections which were caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli, which resulted in 1 death.

The problem started because the scientists in the lab didn't test the donor stool for drug-resistant bacteria before the fecal transplant.

The FDA said the donor stool had not been tested for drug-resistant bacteria (MDROs).

While the FDA does not now approve FMT for any use, the agency provides some guidelines for clinical trials of FMT, and seeks "to strike a balance between assuring patient safety and facilitating access to unapproved treatments for unmet medical needs", said Dr. Peter Marks, director of FDA's Center for Biologics Evaluation and Research, in the FDA statement.

Fecal transplants from a healthy individual can normalize the patients' microbiota, quelling the infection and relieving symptoms.

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The procedure is typically performed through a colonoscopy or by nasoduodenal tube, according to Johns Hopkins Division of Gastroenterology and Hepatology. Both patients received stool from the same donor and had weak immune systems.

The FDA didn't disclose where the stool came from or the organization that provided the transplant. USA Today notes antibiotic-resistant infections kill another 23,000. When the fecal transplant is used, relapse rates are significantly reduced.

In light of the adverse events, the FDA said yesterday it recommends that donor screening questions specifically "address risk factors for colonization with MDROs, and exclusion of individuals at higher risk of colonization with MDROs".

Marks stressed that the FDA still supports research into fecal transplant therapy.

The Food and Drug Administration on Thursday published a bulletin warning against possible complications from faecal microbiota transplantation (FMT), which has been rising in popularity for the treatment of C. diff, a debilitating gut infection.

The drug-resistant E.coli strain found in the patient who died matched with the strain found from the donor. The agency also suggests speaking openly with primary care doctors so that individuals considering the controversial treatment option can better understand the potentially deadly risks of undergoing the transplant.

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