FDA issues safety alert for FMT
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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.”
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Perspective
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The six cases of infectious E.coli and two deaths are unfortunate and reflect the importance of ongoing research to improve the safety of FMT. FMT is effective for recurrent C. diff. We add it to the armamentarium of treatment options for those who have had two or more recurrences of C.diff, and it is more efficacious than antibiotics. Like antibiotics, there are risks associated with the procedure. In FMT, we take stool from a donor and transplant that into the recipient, the individual who suffers from recurrent C. diff.
Stool is a biologic substance. At our institution, we do our best to screen for infectious diseases prior to the transplant. There is a risk that the donor passes on an infection that there is no screen for, or that they acquire an infection between the time in which we test and they donate their stool. As we learn more about the fecal microbiome – which is composed of all the organisms that live in the colon – we are finding that it may be implicated in many processes in the body beyond just infection, such as cancers, fatty liver disease, psychiatric conditions, and coronary artery disease. As such, there may be a potential risk of transplanting organisms involved in these processes. For those reasons, the FDA classifies FMT as an Investigational New Drug.
As part of the FMT protocol in place, we advise our patients to find donors who are relatively healthy. Before a fecal transplant is done, we discuss the benefits, the risks (such as those outlined above), and the alternatives. We also test the donor and the recipient for several infections. Though we take many measures to ensure safety in the process, there is a risk associated with FMT. Efficacy rates at treating recurrent C.diff are higher than 90%, and, in my experience, patients have been extremely satisfied with the results, especially after factoring in the costs associated with hospitalizations, antibiotics, days of work missed, as well as the symptoms caused by C.diff.
Gastroenterologist
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