Patient dead from Superbug infection after fecal transplant, FDA warns



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The strain of E. Drug-resistant coli found in the deceased patient corresponded to the strain found in the donor. Clearly, the donor stool has not been tested for this strain before the transplant. ( Sintija Valucka | pixabay )

The fecal microbiota for transplantation, or more commonly known as fecal transplantation, seems promising for helping to treat various conditions. Now, however, the US Food and Drug Administration warns of the risks it may have after the death of a patient has been linked to the procedure.

Drug-resistant bacteria

On June 13, the FDA issued a public safety alert regarding the use of the FMT after two people who underwent the procedure developed an invasive infection from the same donor.

Clearly, the donor stool was not tested for Escherichia coli (E. coli) prior to the procedure and the drug-resistant bacterium was therefore transmitted to both immunocompromised patients. It was after both patients developed the infections that the donor stool was tested and found to be positive for the same strain of E. coli. Drug resistant coli infecting patients.

Unfortunately, one of the patients eventually died.

Fecal grafts

Until now, fecal transplants are considered experimental treatments for Clostridium difficile, a potentially fatal infection that causes severe diarrhea. Basically, the idea of ​​the procedure is to balance the intestinal bacteria of a patient by transplanting feces from a healthy donor and grafting them into the patient's colon.

In July 2013, the FDA issued guidelines stating that it intended to exercise its discretion in law enforcement under limited conditions regarding the requirements of the law. IND for the use of FMT in the treatment of Clostridium difficile (C. difficile) infection in patients who have not responded to standard treatments "The FDA said in the statement regarding the recent incident.

In the guidelines, referring physicians must obtain the consent of a patient or his legal representative, informing them at least that the treatment is still experimental, as well as potential risks incurred.

MDRO Screening

Due to the incident that caused the death of a patient, the FDA now requires donors to be screened and screened for multidrug-resistant organisms, to be tested. exclusion of potential donors with a higher risk of colonization by MDRO and those who test positive.

Patients who wish to have an FMT are also advised to consult their health care provider to fully understand the potential risks involved in treatment.

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