First Death Caused by Fecal Microbiota Transplant Reported by FDA

Dec, 2019 - By SMI

The U.S. FDA (Food and Drug Administration) recently hit the headlines with the announcement of the death of a 73-year-old man from a fecal microbiota transplant (FMT), another man who fell highly sick after receiving an FMT. According to the doctors, the donor stool, which had been used for the transplant, did contain a rare type of drug-resistant bacteria, known as ESBL (extended-spectrum beta-lactamase)-producing E. coli.

Both the events prompted the U.S. regulator to formulate newer safety guidelines for the FMTs. However, the announcement offered just a little detail about the two cases that left the doctors looking for more accurate information.

Further details have been provided in a study published on October 31, 2019, in the journal New England Journal of Medicine (NEJM).

As per the latest report, the man who died from the transplant had earlier participated in a clinical trial conducted at Massachusetts General Hospital (MGH) and had received certain fecal transplant capsules that contained fecal material of a stool donor. The tests run following the man’s death disclosed that the stool had a rare strain of the drug-resistant bacterium E. coli.

The researchers suggest that fecal microbiota transplants are yet to advance from just being an ‘investigational’ procedure. Fecal transplants have been operated on innumerable people with C. difficile for many years now, which leads to yet another fatal infection that is known to kill over 15,000 people across the U.S each year. Hence, the previous clinical trials show that FMTs are able to cure this infection that is very often persistent. However, a spokesperson of the FDA stated that the procedure is still regarded as ‘investigational’, even in cases of C. difficile infection.

Alexander Khoruts, the Medical Director at the University of Minnesota’s Microbiota Therapeutics Program, “The NEJM report should set off alarm bells for those who thought that this was risk-free. The MGH researchers did the right thing by sharing the details.”