FDA warns of the potential risk of pathogenic bacteria transmission associated with fecal microbiota transplantation
The Food and Drug Administration (FDA) is warning healthcare providers to consider the potential risk of pathogenic bacteria transmission associated with fecal microbiota transplant (FMT) products, which may result in serious adverse reactions.
The agency has been made aware of six reports of infections caused by enteropathogenic Escherichia coli (EPEC) and Shiga toxin-producing Escherichia coli (STEC) that have occurred following investigational use of FMT. It suspects these infections were due to transmission of pathogenic organisms from FMT products supplied by a stool bank company based in the US. Two of these patients died; however, it is unknown whether STEC infection contributed to these deaths.
The FDA previously issued a safety alert in June 2019 warning that FMT may transmit multidrug-resistant organisms, leading to serious or life-threatening infections, particularly in patients who are immunocompromised. This followed two cases of immunocompromised adults who received FMT and developed invasive infections caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli. One of the patients died.
FMT is currently recommended as an option by the Infectious Diseases Society of America/Society for Healthcare Epidemiology of America guidelines for patients with at least two recurrences and where antibiotic therapy has failed.
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Patients usually present with diarrhea, abdominal pain, and leukocytosis, and a history of recent antibiotic use. Other common symptoms include fever, abdominal tenderness, and distension.
Testing should be limited to patients with unexplained, new-onset diarrhea (defined as 3 or more unformed stools in 24 hours). Molecular testing alone or as part of a multistep algorithm is recommended depending on local institutional protocols. May be evidence of pseudomembranes on sigmoidoscopy or colonoscopy in some patients.
Treatment is to discontinue the inciting antimicrobial agent and start therapy with oral vancomycin or fidaxomicin. Surgery may be required in fulminant disease.
About 5% to 50% of treated patients have recurrence after discontinuation of therapy but most respond to a second course of therapy. Fecal microbiota transplantation may be recommended in patients with multiple recurrences.
Infection of the colon caused by the bacteria Clostridium difficile. Characterized by inflammation of the colon and the formation of pseudomembranes. Occurs in patients whose normal bowel flora has been disrupted by recent antibiotic use. Also known as pseudomembranous colitis, CDI, or CDAD. This topic covers the diagnosis and management of adults only.
The US Clinical and Laboratory Standards Institute announced a nomenclature change of the species name from Clostridium difficile to Clostridioides difficile in 2018; however, this name change has not been widely adopted yet.
This topic focuses on the diagnosis and management of C difficile infection in adults only.
History and exam
- antibiotic exposure
- advanced age
- hospitalization or residence in a nursing home
- history of Clostridium difficile-associated disease
- use of acid-suppressing drugs
- inflammatory bowel disease
- solid organ transplant recipients
- hematopoietic stem cell transplant recipients
- chronic kidney disease
- HIV infection
- immunosuppressive agents or chemotherapy
- gastrointestinal surgery
- vitamin D deficiency
Clinical Associate Professor of Medicine
Alabama Infectious Diseases Center
AH declares that he has no competing interests.
Department of Epidemiology
Division of General Medicine and Epidemiology
UNC at Chapel Hill
JA declares that he has no competing interests.
Department of Gastroenterology
John Radcliffe Hospital
SK declares that he has no competing interests.
Clinical Reader and Consultant Gastroenterologist
Norfolk and Norwich University Hospital
IB declares that he has no competing interests.
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