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 Thursday.
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. In its warning Thursday, the agency announced new protections for trials and experimental uses of the procedure.
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. The E. coli strain carried a drug-defeating enzyme called an extended-spectrum beta-lactamase(ESBL), which generally cleaves a ring common to all the chemical structures of those antibiotics. When unnamed researchers who administered the transplant looked back at the donor stool, they found that the stool contained an identical ESBL-producing E. coli.
One of the patients died and the fate of the other was not discussed. The agency also did not say how or why the patients were immunocompromised prior to the transplants, what the transplants were attempting to accomplish, how they were carried out, who conducted the transplants, or when they occurred.
