Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation

Fecal transplants

On June 13, 2019, the Food and Drug Administration (FDA) informed health care providers and patients of the potential risk of serious or life-threatening infections with the use of fecal microbiota for transplantation (FMT).  Bacterial infections caused by multi-drug resistant organisms (MDROs) have occurred due to transmission of a MDRO from use of investigational FMT, resulting in the death of one individual.

Because these serious adverse reactions occurred with investigational FMT, FDA has determined that additional protections are needed for any investigational use of FMT.  FDA has notified all Investigational New Drug (IND) holders of these requirements and that they need to implement these new requirements no later than July 15, 2019.

FDA has received inquiries from non-IND holders since the release of the June 13, 2019 safety communication, such as those who may be using FMT under enforcement discretion, regarding the additional screening and testing procedures. 

For details, see: https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/information-pertaining-additional-safety-protections-regarding-use-fecal-microbiota-transplantation

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology