March 27, 2020

Fecal microbiota transplant (FMT) as a treatment for C. difficile infections has skyrocketed over the past decade. While it has saved tens of thousands of lives, FMT remains controversial and the Food and Drug Administration (FDA) has been slow to formalize its regulatory status. This has left doctors, scientists, drug …

March 23, 2020

The Food and Drug Administration (FDA) issued a Safety Alert today Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to COVID-19. According to the alert, “FDA is informing health care providers and patients of the potential risk of transmission of SARS-CoV-2 virus by the use of fecal …

March 15, 2020

On March 12, the Food and Drug Administration (FDA) issued a safety alert that eight patients were infected following fecal microbiota transplants (FMT) using material from a company which was later confirmed to be OpenBiome, an independent stool bank. Two of the patients subsequently died. FDA did not name OpenBiome …