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June 16, 2019

FDA warns against fecal transplant treatment after one patient dies

FMT is an experimental treatment for C. difficile infection

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FDA fecal transplant treatment for C. difficile

FDA warns against fecal transplant procedures for C. difficile after one person dies from contracting E. coli.

The U.S. Food and Drug Administration issued a warning after a patient died following a fecal transplant procedure to treat C. difficile.

Clostridium difficile is an infection of the intestines that can be deadly. When other treatment options, such as antibiotics, do not work, C. difficile can be treated with fecal microbiota transplantation. The procedure includes transferring a stool from a healthy donor to an infected individual's intestines to help repopulate good bacteria in their gut. The treatment has not yet been approved by the FDA and is considered to still be under investigation. 

The FDA reported two patients who received the FMT procedure both developed invasive infections that was spread by E. coli. One of the patients died.

The two patients received a stool from the same donor, which the FDA claims was not tested for E.Coli or other ESBL-producing gram-negative organisms prior to use. After the two patients became sick, the stool was then tested for E. coli and it came back positive for the same E. coli strain infected in the two patients.

The FDA listed two protections for use in fecal transplant treatments. The first is to screen donors by asking them questions regarding any potential exposure to multi-drug resistant organisms (MDRO). The second is to test donor stools and exclude any stools that test positive for MDRO. 

According to the CDC, over 500,000 patients get infected with C. difficile every year. Nearly 29,000 patients die within 30 days of initial diagnosis. 80 percent of the deaths associated with the infection were in individuals 65 or older. Poor infection control and unnecessary antibiotic use can lead to a C. difficile infection.

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