The US Food and Drug Administration (FDA) is warning
health care providers and patients about serious risks associated with fecal microbiota for transplantation (FMT). This warning comes after the FDA was made aware of bacterial infections caused by multidrug-resistant organisms have occurred following transmission during FMT, which is not approved by the FDA.
“The medical community is actively engaged in exploring the potential uses of Fecal Microbiota for Transplantation, or FMT,” said Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research in a briefing
. “Although FMT is not approved by the FDA for any use, the agency plays a critical role in supporting product development while assessing the risks and benefits to patients of unapproved therapies.”
According to the FDA, 2 immunocompromised individuals who received the investigational FMT developed invasive infections which were caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli
, which resulted in 1 death.
“Today’s safety communication underscores the importance of why new therapies are thoroughly studied to ensure the benefits of taking them outweigh the risks to patients, and we will continue to aggressively monitor clinical trials to ensure patients are protected when safety concerns arise,” Marks continued.
Both of these individuals underwent FMT prepared from stool obtained from the same donor. The agency notes that the donor stool used in these 2 individuals were not tested for ESBL-producing gram-negative organisms prior to use in the FMT. After the detection of these events, stored preparation of FMT from the stool donor were tested and found to be positive for ESBL-producing E coli
which was identical to the organism isolated from the patient.
Because of these incidents, the FDA is advising that health care providers should take additional cautions prior to any investigational use of FMT. These precautions include: screening donors to evaluate risk factors for colonization with multidrug-resistant organisms and exclusion of individuals at a higher risk for being colonized with these organisms; and testing of donor stool for multidrug-resistant organisms should occur and stool that tests positive for these organisms should be excluded.
“The agency intends to exercise enforcement discretion regarding the [Investigational New Drug] requirements for the use of FMT to treat C difficile
infections in patients who have not responded to standard therapies provided that the treating physician obtains adequate informed consent, which should include a statement that the use of FMT to treat C difficile
is investigational and a discussion of potential risks,” the statement concludes.
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