On June 13, FDA issued a safety alert reporting that two patients contracted severe infections, and one of them died, from fecal microbiota transplants (FMT) that contained a multi-drug resistant organism (MDRO). Both patients received stool from the same donor, which later tested positive for extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E.coli).
Important things to know:
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- FDA is working with clinical trial sponsors to ensure donor screening includes questions on risk factors for colonization with MRDO and MDRO testing of donor stool. On June 18, they released guidance for enhanced donor screening.
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- In addition to enhanced donor screening as recommended by FDA, physicians must review the potential risks with all patients considering FMT.
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- FMT is an investigational treatment. FDA’s current “enforcement discretion” guidance, which allows physicians to perform FMT without an investigational new drug application, applies only to the treatment of Clostrididoides difficile (C. difficile) infection that is not responsive to standard therapies. For all other indications, FMT should only be done as part of a clinical trial.
AGA is committed to advancing applications of the gut microbiome. Our top priority is ensuring patient safety from microbiome-based therapeutics, such as FMT.
AGA will continue to monitor this issue and will keep members abreast of developments. Through the AGA FMT National Registry, AGA is working with physicians and patients to track FMT usage, patient outcomes and adverse events. Associated with the registry is a biorepository of donor and patient stool samples, which will allow further investigation of unexpected events such as those described in FDA’s safety alert.
“For many of our patients suffering from recurrent C. difficile infection, FMT is a lifesaving procedure. However, we recognize there are unknown in terms of risks of FMT, and that’s why AGA established the FMT National Registry. The registry is a much-needed initiative to identify long-term adverse events. In the meantime, all physicians performing FMT should be diligent about donor screening, patient selection, and having frank conversations about benefits and risks with patients.” — Colleen Kelly, MD, Co-Principal Investigator of the AGA FMT National Registry.
“For many of our patients suffering from recurrent C. difficile infection, FMT is a lifesaving procedure. However, we recognize there are unknown in terms of risks of FMT, and that’s why AGA established the FMT National Registry. The registry is a much-needed initiative to identify long-term adverse events. In the meantime, all physicians performing FMT should be diligent about donor screening, patient selection, and having frank conversations about benefits and risks with patients.” — Colleen Kelly, MD, Co-Principal Investigator of the AGA FMT National Registry.The FMT National Registry is supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number R24AI118629.
