Two adults with compromised immune systems who received fecal transplants developed invasive drug-resistant bacterial infections, one of whom died, prompting the Food and Drug Administration (FDA) to issue a safety communication warning that fecal microbiota for transplant (FMT) may transmit multidrug-resistant organisms leading to serious or life-threatening infections.

According to the FDA, both patients received FMT from the same donor and developed extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E.coli). After both patients fell ill, the donor’s FMT tested positive for ESBL-producing E.coli.

FMT is not approved by the FDA for any use, but the agency is playing a critical role in supporting the development of fecal transplant treatments while balancing patient safety with access to unapproved treatments for unmet medical needs, said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

In 2013, the FDA issued a guidance that it would exercise enforcement discretion with regard to investigational new drug requirements for fecal transplants to treat clostridium difficile (C.diff) infections in patients who don’t improve with standard treatments. The Centers for Disease Control and Prevention (CDC) consider C.diff a major health threat, causing life-threatening diarrhea. C.diff is a substantial cause of infectious disease death in the U.S.

The FDA’s guidance requires physicians to obtain patient consent before treating them with FMT, which also informs them that fecal transplants as a treatment for C.diff is investigational.

Since the two patients fell ill, the FDA has halted an undisclosed number of clinical trials involving FMTs until researchers involved in the studies ensure their donor stool does not contain dangerous bacteria.

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