A new safety alert, issued by the Food and Drug Administration (FDA), is recommending extra precautions for those medical and scientific professionals using fecal microbiota transplants (FMT) after revealing one person recently died due to a bacterial infection.

The safety alert from the FDA reports two adverse events occurring in the course of clinical investigations using FMT. Two adults, with compromised immune systems, were administered FMT and developed major infections from multi-drug resistant organisms (MDROs) present in the donor stool. One of the two patients subsequently died from the infection.

The FDA reports the donor stool was tested and found positive for extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli bacteria. According to a report in The New York Times, the FDA has immediately suspended a number of clinical trials currently underway using FMT until each trial can be shown to have effectively screened for dangerous bacterial organisms.

"While we support this area of scientific discovery, it's important to note that FMT does not come without risk," says 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. 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."

No information has been supplied at this stage regarding the specifics of what clinical trial these adverse events occurred in, or who was providing the treatment. However, the FDA has determined specific MDRO testing be implemented in all future FMT investigations, and more detailed discussions with patients over the risks of FMT procedures be instituted during the consent stages in future trials.

As research into the gut microbiome, and fecal transplants, rapidly expands, the FDA alert offers a much needed wake-up call to the dangers of this still relatively unexplored area of medicine. It is a reminder that FMT is not a harmless procedure and should be undertaken with caution under the close oversight of medical professionals.

Source: FDA (1) (2)