Patients who receive fecal microbiota for transplant (FMT) are at risk of life-threatening infections, the Food and Drug Administration said.
Two adults who received FMT from the same donor developed infections caused by extended-spectrum beta-lactamase-producing Escherichia coli.
The FDA is advising that donors are questioned about risk factors for multidrug-resistant organisms.
“While we support this area of scientific discovery, it's important to note that FMT does not come without risk,” said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. “We've become aware of infections with multi-drug resistant organisms after patients received investigational FMT, including one patient death. We therefore want to alert all health care professionals who administer FMT about this potential serious risk so they can inform their patients.”
Currently, FMT is not approved by the FDA and the FDA issued guidance that requires patients to be made aware of the fact that FMT is investigational for the treatment of Clostridium difficile.