FDA issues safety alert for FMT
Two patients died and four were hospitalized after receiving fecal microbiota transplantations from OpenBiome stool donors, according to a safety alert from the FDA and a press release from the company.
The agency said it is now aware of infections caused by enteropathogenic Escherichia coli (EPEC) and Shigatoxin-producing Escherichia coli (STEC) that have occurred following investigations of FMT use. Two patients who received FMT for recurrent Clostridioides difficile infection developed infections caused EPEC and four developed infections caused by STEC. Four of the six required hospitalization, and an additional two patients died, according to the FDA. It is unknown if the deaths can be attributed to STEC infection, the agency said in the alert.
While OpenBiome was not named in the FDA safety alert, the company issued a press release saying the patients were treated by FMT from OpenBiome donors.
“We received four reports of patients who were treated with investigational FMT for recurrent Clostridioides difficile infection who later tested positive for STEC,” the company said in the release. “All were treated with material from one donor. Two were hospitalized and have since been discharged; two were treated as outpatients and their symptoms have resolved.
“We received two additional adverse event reports for patients who received material from this donor that are likely unrelated to their FMT. Both had multiple pre-existing conditions. Both have passed away from unrelated causes.”
In response, the company will recall and destroy any unused material supplied by the donor and add PCR testing for STEC to its donor screening process.
OpenBiome also received reports of two patients who tested positive for EPEC who were treated with FMT from two different donors. One was hospitalized for related symptoms, and the other was hospitalized for unrelated causes. Both have since been discharged, according to the release. In addition to recalling and destroying material previously collected from these donors, OpenBiome will implement EPEC testing to its donor screening protocol.
The FDA is informing patients and providers of the potential risk for transmission and advised patients considering FMT to speak to their physicians to understand the associated risks.
OpenBiome said it is working with the FDA to implement retrospective screening of stool donations to ensure that material is up to the new standards. Any material that has not been recalled is not on hold and may be used.
“In collaboration with our network of clinical partners, who provide important follow-up information on the patients they treat, we work to identify and respond quickly to any emerging safety signals,” the company said in the release. “We are currently conducting a full investigation and will share the results to inform safety in the field more broadly.”