Officials at the Food and Drug Administration have issued a safety alert regarding the use of fecal microbiota for transplantation (FMT) and the risk of serious adverse reactions because of transmission of multidrug-resistant organisms (MDROs).
Dr. Lea Ann Chen
According to the alert, which was issued on June 13, 2019, the agency became aware of two immunocompromised adult patients who received investigational FMT and developed infections caused by extended-spectrum beta-lactamase (EBSL)–producing Escherichia coli. One of the patients died.
“This is certainly a theoretical risk that we’ve known about,” Lea Ann Chen, MD, a gastroenterologist at New York University, said in an interview. “This announcement is important, because we probably don’t counsel patients specifically about this risk. We say there is a risk for transmission of infectious agents in general, but I think that probably very few counsel patients about a risk for transmission of MDROs.”
The donor stool and FMT used in the two patients were not tested for ESBL-producing gram-negative organisms prior to use. As a result of these serious adverse reactions, the FDA has determined that certain donor screening and stool testing protections are needed for any investigational use of FMT. On June 18, the agency released an additional statement, which stipulated that all Investigational New Drug (IND) holders must implement the following new requirements no later than July 15, 2019:
“1. Donor screening must include questions that specifically address risk factors for colonization with MDROs, and individuals at higher risk of colonization with MDROs must be excluded from donation. Examples of persons at higher risk for colonization with MDROs include:
a. Health care workers
b. Persons who have recently been hospitalized or discharged from long-term care facilities
c. Persons who regularly attend outpatient medical or surgical clinics
d. Persons who have recently engaged in medical tourism
