Warning on risks of serious adverse events with use of fecal microbiota for transplantation

The FDA is informing clinicians of the potential risk of transmission of pathogenic bacteria with the use of fecal microbiota for transplantation (FMT).

In a March 12 safety alert, the agency reported that infections caused by enteropathogenic Escherichia coli and Shiga toxin-producing Escherichia coli have occurred following investigational use of FMT. The FDA suspects that these infections are due to transmission of these pathogenic organisms from FMT product supplied by a U.S.-based stool bank company that manufactures it from prescreened donors and provides it to clinicians and researchers.

The FDA is aware of six patients who received the company's FMT product for Clostridioides difficile infection not responsive to standard therapies and who developed infections caused by enteropathogenic Escherichia coli (two patients; two different stool donors) or Shiga toxin-producing Escherichia coli (four patients; a single donor). Four of the six patients required hospitalization. Two additional patients with chronic medical conditions died following receipt of FMT product from the donor associated with the Shiga toxin-producing Escherichia coli infections; it is unclear if the infection contributed to these deaths, the FDA said.

“Patients considering FMT for the treatment of C. difficile infection should speak to their health care provider to understand the associated risks,” the FDA recommended.

In a March 23 update, the FDA noted that recent evidence has shown that individuals infected with SARS-CoV-2 may have the virus in their stool. “This information suggests that SARS-CoV-2 may be transmitted by FMT, although the risk of such transmission is unknown,” the FDA said in a safety alert. The agency recommended testing donors and/or donor stool for SARS-CoV-2, as feasible.