Seres Therapeutics Issues Statement Regarding U.S. Food and Drug Administration’s March 12, 2020 Safety Alert Related to Use of Fecal Microbiota Transplantation
Seres Therapeutics, Inc. (MCRB)
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Source: Business Wire
FDA alert is related to unapproved fecal microbiota transplantation (FMT) and does not impact Seres’ investigational microbiome therapeutic candidates CAMBRIDGE, Mass.--(BUSINESS WIRE)--Seres Therapeutics, Inc. (Nasdaq: MCRB) today provided a statement on a safety alert from the U.S. Food and Drug Administration (FDA) regarding bloodstream infections with multi-drug resistant organisms (MDROs) transmitted through fecal microbiota transplantation (FMT). On March 12, 2020, the FDA stated that it became aware of six infections caused by enteropathogenic Escherichia coli (EPEC) and Shiga toxin-producing Escherichia coli (STEC) that have occurred following investigational use of FMT. The FDA suspects that these infections were due to transmission of pathogenic organisms from FMT product supplied by a stool bank company based in the United States. Four of the six patients who received the contaminated FMT required hospitalization. An additional two patients who received FMT from the STEC
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