FDA issues safety alert over fecal transplants after patient’s death

The Food and Drug Administration headquarters in White Oak Md

Enlarge The Food and Drug Administration headquarters in White Oak

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 FDA said the two patients, who were immunocompromised, developed E. coli infections after receiving fecal transplants from the same donor. The donor sample was not tested for the bacteria before use.

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While it's not clear why the patients had received fecal transplants, procedure has been used to treat C. difficile colitis, a complication of antibiotic therapy.

The treatment hasn't yet been approved by the FDA.

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. It involves taking fecal matter from a healthy donor and delivering it into a patient's colon, either directly, through an enema or other infusion of stool, or with the use of "poop pills", capsules containing fecal matter that patients take by mouth. The CDC estimates that at least 2 million Americans develop drug-resistant bacterial infections every year, and at least 23,000 die.

Because of the "serious adverse reaction" the FDA said they are adding restrictions to the clinical trials.

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