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 strained 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.