Patient Dies After Receiving Fecal Transplant That Contained Drug-Resistant Bacteria

By Kristin J. Kelley

Edited by Susan Sadoughi, MD

The FDA issued a safety warning late last week about the potential risk for serious infections associated with the use of fecal microbiota transplantation (FMT). One immunocompromised patient died, and a second was infected, after receiving FMT preparations containing extended-spectrum β-lactamase (ESBL)-producing Escherichia coli.

The stool samples used in both cases were from the same donor. The samples were not screened for ESBL-producing gram-negative organisms before being used.

In response to these cases, the FDA is asking that new protocols be put in place for patient safety. Stool from donors should be screened for multidrug-resistant organisms, and potential donors must be asked about risk factors for colonization with such organisms.

According to guidance issued in 2013, the FDA considers FMT to be an investigational new drug that clinicians can use to treat Clostridium difficile infection in patients unresponsive to standard therapies. FMT has also been studied in irritable bowel syndrome and ulcerative colitis.