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# Safety Alert on Fecal Microbiota For Transplantation
- URL: https://www.fdaweb.com/safety-alert-on-fecal-microbiota-for-transplantation/
- Published: 2019-06-13T12:00:00.000Z
- Updated: 2026-09-15T01:32:27.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144335

An FDA [safety alert](https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/important-safety-alert-regarding-use-fecal-microbiota-transplantation-and-risk-serious-adverse?ref=fdaweb.com) warns about infections with multi-drug resistant organisms after patients received investigational fecal microbiota for transplantation (FMT), including one patient death. “Two immunocompromised adults who received investigational FMT developed invasive infections caused by extended-spectrum beta-lactamase (ESBL)-producing *Escherichia coli* (*E.coli*),” the alert says. The donor stool and resulting FMT used in these two individuals were not tested for ESBL-producing gram-negative organisms prior to use, the agency says.

  
Because of these serious adverse reactions, FDA says that extra protections are needed for any investigational use of FMT. For example, it recommends donor screening with questions that specifically address risk factors for colonization with multi-drug resistant organisms, and exclusion of individuals at higher risk of colonization. And, it recommends donor stool testing for multi-drug resistant organisms and exclusion of donors testing positive.