ABOVE: Illustration of human microbiota samples under a microscope
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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 ...
