FDA Issues Fecal Transplantation Safety Alert

Fecal microbiota transplantation (FMT) receives an FDA safety alert due to adverse reactions in two individuals who underwent FMT and received stool from the same donor. The stool, infected with extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E. coli) – a multi-drug resistant organism (MDRO) and therefore very challenging to treat – was administered to two immunocompromised adults, resulting in one death. FDA

Takeaway: The FDA identified that more screening is needed throughout the stool donor process, including specific questions addressing risk factors for MDRO stool colonization and rejection for those donors who are at high risk – as well as testing for MDRO colonization in donor stool.

FMT is an FDA approved therapy for recurrent C. diff. While research shows that FMT may result in positive improvements for some other conditions – inflammatory bowel disease (Crohn’s disease and ulcerative colitis), infectious diarrhea, irritable bowel syndrome, and severe antibiotic-associated diarrhea – the scientific evidence is still weak in many of these areas, and FMT as an effective treatment for these conditions is not FDA approved.