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FDA Warns of Infections From Fecal Transplants After One Death

FRIDAY, June 14, 2019 -- On Thursday, federal health officials announced that a patient has died after fecal microbiota transplantation, highlighting the potential for severe infections linked to the procedure.

"While we support this area of scientific discovery, it's important to note that fecal microbiota for transplantation does not come without risk," Peter Marks, M.D., Ph.D., director the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration, said in a statement. After reports of serious, antibiotic-resistant infections linked to the procedures, the FDA wants "to alert all health care professionals who administer fecal microbiota transplant about this potential serious risk so they can inform their patients," Marks added.

Fecal microbiota transplant is a still-experimental procedure, as yet unapproved by the FDA. It has been primarily used to treat serious infections of antibiotic-resistant forms of the Clostridium difficile bacterium. But every therapy comes with risks, and the FDA said that two patients who received fecal microbiota transplants as part of a clinical trial developed life-threatening infections from multidrug-resistant bacteria delivered in the transplants. One of the patients has died. Both patients had weakened immune systems. So, the FDA is now mandating that special screening and testing of the stool used in these procedures be done to ensure that no drug-resistant bacteria are in the donated material. Also, when fecal microbiota transplants are used, doctors need to have adequate informed consent from the patient, the FDA said. Patients need to be warned of any potential risks associated with the treatment and should be told that the treatment is still considered experimental.

Marks stressed that the FDA still supports research into fecal transplant therapy. "The medical community is actively engaged in exploring the potential uses of fecal microbiota for transplantation," he said. To that end, "we will continue to aggressively monitor clinical trials to ensure patients are protected when safety concerns arise."

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Posted: June 2019

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