Fecal transplant death sparks new FDA screening precautions, pause of clinical trials

bo fecal transplants feat
Fecal microbiome pills. Image: Marc Bruxelle/Shutterstock

One patient has died and another became seriously ill after fecal transplants inadvertently seeded their innards with a multi-drug resistant bacterial infection, the Food and Drug Administration warned [June 13].

The cases highlight the grave risks of what some consider a relatively safe procedure. They also call attention to the mucky issues of federal oversight for the experimental transplants, which the FDA has struggled to regulate. 

The FDA shared minimal details from the deadly transplants. Its warning only noted that the cases involved two patients who were immunocompromised prior to the experimental transplants and received stool from the same donor. Subsequent to the transplant, the patients developed invasive infections from an E. coli strain that was resistant to a wide variety of antibiotics in the penicillin and cephalosporin groups.

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The agency now says that FMT stool donors and stool itself need to be screened for multidrug-resistant organisms and excluded if they’re found to harbor any. A regulator with the FDA told the New York Times that the agency is also pausing clinical trials involving FMTs until it’s clear that they have such safety precautions in place.

Read full, original post: One dead after poop transplant gone wrong, FDA warns

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