One patient died and four were hospitalized after receiving OpenBiome stool transplants as a treatment for Clostridium difficile, the FDA said in a March 12 safety alert.
In total, six patients developed E. coli infections after receiving stool transplants. One other did not contract an infection, but died from underlying medical conditions. The FDA said it suspects the stool, donated from three separate donors, contained infection-causing bacteria. OpenBiome identified two different types of E. coli in stool samples from the six living patients. The FDA said it is still not known if the stool transplant contributed to the patient's death.
OpenBiome is collaborating with the FDA to change its screening program and ensure stool is properly screened for pathogens. OpenBiome issued a recall on all material from the three donors, and all affected facilities have destroyed the recalled units.
"Across over 55,000 treatments shipped, these six cases are the first likely transmission of pathogens from our materia," a spokesperson for OpenBiome told Becker's via email. "We have never received a report of a patient death definitively caused by OpenBiome material."
Editor's note: This article was updated March 13 at 9:00 a.m. and March 16 at 8:15 a.m. to provide additional information.