FDA Issues Safety Alert After 6 People Are Infected With Pathogenic E.coli From Fecal Transplant

The FDA issued a safety alert about the transmission of pathogenic E.coli in patients who received fecal microbiota transplant (FMT) from a stool bank company based in the U.S. Two additional patients, who had chronic medical conditions, died. All of the infected patients received FMT for treatment of C. difficile, which causes inflammation of the colon.

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Four of the six patients were hospitalized. Two of them developed infections caused by enteropathogenic E.coli (EPEC) and four developed infections caused by Shiga toxin-producing E.coli (STEC). The two patients with EPEC infections received FMT product from stool from two different donors, while the four patients with STEC infections received FMT product from stool from a single donor. The patients who died received FMT product from the donor associated with the STEC infections.

OpenBiome, a stool bank company based in Boston, issued a press release in response to the FDA’s alert stating that the infected patients received FMT product that came from three OpenBiome donors. OpenBiome claims that the company immediately implemented changes to its screening program in order to ensure that FMT material is properly screened moving forward.

What is FMT?

Fecal microbiota transplant (FMT) is an investigational procedure that involves transferring the stool of a healthy donor to the intestines of a sick person in order to produce good bacteria and fight infection. The procedure is commonly used for the treatment of C. difficile when patients do not respond to standard treatment options. Researchers have been exploring the use of FMT for conditions ranging from Alzheimer’s to autism.

Understanding the Risk Factors Associated with FMT

The FDA recommends that patients considering FMT to treat C. difficile infections speak to their healthcare providers to understand potential risks. Unfortunately, this is not the first time that FMT patients developed fatal E.coli infections. In June of 2019, two patients died from drug-resistant strains of E.coli transmitted by FMT.

E.coli Legal Team

Our team of E.coli lawyers helps people who develop pathogenic and multi-drug resistant E.coli infections due to medical malpractice. When a medical procedure results in death due to negligence, the family may be able to sue for wrongful death. Recently, our lawyers obtained a $950,000 settlement in a medical malpractice case involving an infection. For a free consultation, please fill out the form below or call 1-888-377-8900.

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