FDA Suspends Clinical Trials Involving Fecal Transplants
FDA Suspends Clinical Trials Involving Fecal Transplants

FDA Suspends Clinical Trials Involving Fecal Transplants

The agency issued a safety warning after two patients contracted antibiotic-resistant infections and one of the patients died.

Jun 14, 2019
Chia-Yi Hou

ABOVE: Illustration of human microbiota samples under a microscope
© ISTOCK.COM OLEKSANDR KHOMA

The US Food and Drug Administration issued a safety alert for fecal transplant procedures after two immune-compromised patients contracted drug-resistant infections, according to a statement from the agency’s website. The patients received transplants from the same donor, and one of the patients died. As a result, the agency plans to suspend clinical trials involving the procedure, The New York Times reports.

Fecal microbiota transplants (FMT) are not yet officially approved by the US Food and Drug Administration (FDA). “While we support this area of scientific discovery, it’s important to note that FMT does not come without risk,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, says in a brief statement on the agency’s website. Marks does not state how many clinical trials will be affected, but tells The Times it was “not just a few.”

The FDA warns that fecal matter should be tested for drug-resistant bacteria. “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 says in the statement.