US FDA issues new safety alert on Fecal Transplant (FMT)

On March 12, the US FDA has issued a Safety Alert as it has become aware of eight potential cases of serious adverse events in patients who received FMT for C. difficile infection not responsive to standard therapy. Out of these eight cases, four required hospitalization and two died.

- Two patients suffered infections caused by EnteroPathogenic Escherichia coli (EPEC). These patients had received their transplants from different donors.

- Four patients, who received their FMT from a single donor, developed infections caused by ShigaToxin-producing Escherichia coli (STEC).

- The two additional patients who died had received their FMT from the donor associated with the four STEC infections mentioned above. Although it is not known if STEC infection contributed to these deaths as their stool was not tested for this specific pathogen, it was recorded that both patients had developed diarrhea after receipt of the FMT.

This warning comes less than a year after a previous Safety Alert in which the FDA informed about two cases of immunocompromised patients which had developed invasive infections caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli after receiving an FMT from the same donor. One of these patients died.