The FDA has issued a new advisory that reveals one patient has died as a consequence of an investigational fecal microbiota transplant (FMT). Though the agency doesn’t oppose these investigational studies into the potential benefits of FMTs, it warns that there are serious risks associated with undergoing the treatment, namely the transmission of bacteria that is resistant to a variety of drugs.
Fecal transplants involve the transplantation of fecal bacteria from one individual to another. A number of studies have looked at the potential health benefits associated with transplants from healthy individuals into individuals with obesity, autism, and C. difficile infections resistant to typical treatments.
Though the transplants have shown some promise in early investigational work, the FDA has published a new study warning that there are some serious risks involved with the practice, and that health providers should advise their patients of these risks before they undergo the treatment.
According to the agency, it learned that two immunocompromised adults who received investigational fecal transplants ended up contracting ‘invasive bacterial infections’ from them. The infections were resistant to many of the drugs that are used to treat the issues, and tragically one of the two patients died as a result.
The FDA’s Center for Biologics Evaluation and Research director Peter Marks, MD, PhD, said:
While we support this area of scientific discovery, it’s important to note that FMT does not come without risk. We’ve become aware of infections with multi-drug resistant organisms after patients received investigational FMT, including one patient death. We therefore want to alert all health care professionals who administer FMT about this potential serious risk so they can inform their patients.