Patient Dies After Fecal Transplant, the FDA Warns
The Food and Drug Administration has issued a warning to health care providers and patients after an individual died as a result of a fecal transplant.
According to the FDA warning issued on their website on Thursday, two adults with weak immune systems who received investigational fecal transplants developed invasive infections, causing one of the patients to die. The infections produced E.Coli in their systems. The statement added that the fecal matter used in the two patients originated from stool that came from the same donor.
Fecal transplants treat severe intestinal disorders by introducing stool from a healthy donor in an attempt to restore a normal balance of bacteria in the intestine.
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The FDA said the donor stool had not been tested for drug-resistant bacteria (MDROs). “FDA is informing members of the medical and scientific communities and other interested persons of the potential risk of transmission of MDROs by [fecal transplant] and the resultant serious adverse reactions that may occur,” the warning said.
The agency also listed protections that they consider important for any fecal transplants, including donor screening with questions that address risk factors and testing of the donor stool.
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