Gastroenterology

FDA issues safety alert for FMT



Two patients died and four were hospitalized after receiving fecal microbiota transplantations from OpenBiome stool donors, according to a safety alert from the FDA and a press release from the company.
The agency said it is now aware of infections caused by enteropathogenic Escherichia coli (EPEC) and Shigatoxin-producing Escherichia coli (STEC) that have occurred following investigations of FMT use. Two patients who received FMT for recurrent Clostridioides difficile infection developed infections caused EPEC and four developed infections caused by STEC. Four of the six required

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