One person died from a fecal transplant, the US Food and Drug Administration announced on Thursday, as they issued a warning against the treatment. The idea behind the procedure, known as fecal microbiota transplatation, is to use stool from a healthy person to transfer good bacteria to the intestines of an infected person. Fecal transplants have started being used increasingly to treat intestinal disorders, particularly cases of Clostridium difficile, or C. diff, that haven’t responded to antibiotics. The treatment hasn’t yet been approved by the FDA. The FDA said that two people with weakened immune systems who got transplants from the same donor developed a form of E. coli and one of them died. The donor sample wasn’t tested for the bacteria before it was used. Because of the “serious adverse reaction” the FDA said they are adding restrictions to the clinical trials. All stool samples used in transplants will now be tested for drug-resistant microorganisms and all donors will also need to be screened for potential drug-resistant infections.
FDA issues safety alert over fecal transplants after patient’s death
One person died from a fecal transplant, the US Food and Drug Administration announced on Thursday, as they issued a warning against the treatment. The idea behind the procedure, known as fecal microbiota transplatation, is to use stool from a healthy person to transfer good bacteria to the intestines of an infected person. Fecal transplants have started being used increasingly to treat intestinal disorders, particularly cases of Clostridium difficile, or C. diff, that haven’t responded to antibiotics. The treatment hasn’t yet been approved by the FDA. The FDA said that two people with weakened immune systems who got transplants from the same donor developed a form of E. coli and one of them died. The donor sample wasn’t tested for the bacteria before it was used. Because of the “serious adverse reaction” the FDA said they are adding restrictions to the clinical trials. All stool samples used in transplants will now be tested for drug-resistant microorganisms and all donors will also need to be screened for potential drug-resistant infections.
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