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FDA issues new safety alert on FMT - third one in less than a month

Updated: Apr 10




The FDA has issued a new safety alert on Fecal Transplant (FMT), a type of microbiome therapy, by which the Administration establishes the necessity to test all new donors and all already stored stool material for enteropathogenic Escherichia coli (EPEC) and Shigatoxin-producingEscherichia coli (STEC). This alert is the third one on this topic in less than a month, and the fourth one in less than a year.


This warning comes after a previous one (March 23, 2020) in which the Administration established the necessity to test for SARS-CoV-2 in all fecal material collected after December 1, 2019 and another one (March 12, 2020, updated March 13) in which the FDA already alerted about the potential transmission of EPEC and STEC through FMT after it became aware of some adverse events, some of which were fatal.


Less than a year ago (June 13, 2019) the the FDA informed about two cases of immunocompromised patients which had developed invasive infections caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli after receiving an FMT from the same donor.

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