Key points from article :
FDA issued a safety alert for fecal microbiota transplants (FMTs) from OpenBiome stool donors.
Two patients died and four were hospitalized after receiving FMTs contaminated with pathogens
OpenBiome confirmed the infections and is recalling unused material from the implicated donors.
These events highlight potential risks associated with FMT and the importance of careful donor screening and safety protocols.
The company is adding PCR testing for STEC and EPEC to its donor screening process.
FDA advises patients considering FMT to discuss the risks with their physicians.
OpenBiome is working with the FDA to retrospectively screen stool donations and ensure safety.
