FDA warns fecal transplants may contain deadly drug-resistant bacteria

FDA warns of one patient death from a fecal transplant

FDA warns of one patient death from a fecal transplant

The FDA, which has not approved FMT for clinical use, said both patients were immunocompromised.

The FDA is warning against possible complications from faecal transplants after one person died and another was sickened. The infections were resistant to numerous drugs that are used to treat the issues, and tragically one of the two patients died as a result.

Fecal transplants have become a hot topic in recent years, and doctors have warned against their use in the vague "wellness" space which promises indistinct immune and gut health benefits from the treatment. The statement added that the fecal matter used in the two patients originated from stool that came from the same donor.

But determining who a good donor is by no means as simple as asking around to friends and family about who has regular bowel movements.

The stool was found to have E. coli bacteria that produced an enzyme called extended-spectrum beta-lactamase, making it resistant to multiple antibiotics.

The FDA has issued a new advisory that reveals one patient has died as a effect of an investigational fecal microbiota transplant (FMT). It's been primarily used to treat serious infections of antibiotic-resistant forms of the Clostridium difficile (C. difficile) bacterium. After the illness and death occurred a stored preparation of the donor stool was tested and it was found to be positive for the identical strain of drug resistant bacteria found within the two transplant recipients. The FDA considers these other areas of research experimental. When things got worse, a sample from the donor stool was tested, and the results show E. coli. Recurrent bouts of the infection are also increasingly resistant to antibiotics, leaving patients with few options.

Fecal Transplants have been on the rise as way to treat severe intestinal disorders.

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". Patients are to consider fecal transplants a last resort. As interest in the benefits of fecal transplant grows, the potential need for better regulation is being brought to the fore.

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. "We therefore want to alert all health care professionals who administer FMT about this potential serious risk so they can inform their patients".

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