Fecal transplants involve the transplantation of fecal bacteria from one individual to another.
The FDA announced on Thursday a patient recently died after receiving a fecal transplant, in which healthy fecal matter from a donor is processed in a lab and given to a patient via an infusion or pills in an attempt to reset the intestine's bacteria.
In its safety alert, the FDA outlined how two patients with compromised immune system received fecal microbiota for transplantation (FMT) during a clinical trial.
The FDA will now require screening of donor stool for multidrug-resistant organisms before the stool's use in any FMT procedure.
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When E.coli produces ESBLs and is therefore resistant to drugs, the infection becomes much more hard to treat. Fecal transplants are not now approved by the FDA for any use.
"In July 2013, FDA issued guidance stating that it intends to exercise enforcement discretion under limited conditions regarding the IND requirements for the use of FMT to treat Clostridium difficile (C. difficile) infection in patients who have not responded to standard therapies", the FDA said in the statement regarding the recent incident.
The procedure is typically performed through a colonoscopy or by nasoduodenal tube, according to Johns Hopkins Division of Gastroenterology and Hepatology. The patients received transplants from the same donor, and one of the patients died. Recurrent bouts of the infection are also increasingly resistant to antibiotics, leaving patients with few options. When the fecal transplant is used, relapse rates are significantly reduced. Interest in fecal transplants has also extended into more unexpected realms, like autism. This resulted in the Food and Drug Administration halting a number of clinical trials until researchers can prove that they have procedures in place to screen donated stools for risky bacteria, stated Dr. Peter Marks, the director for the agency's Center for Biologics Evaluation and Research. Patients need to be warned of any potential risks associated with the treatment and be told that the treatment is still considered experimental. Many who have tried a fecal transplant said it improved their symptoms, which can be tempting for those with chronic and debilitating symptoms when many other treatments have failed.
"While we support this area of scientific discovery, it's important to note that FMT does not come without risk", Peter Marks, M.D., Ph.D., director of FDA's Center for Biologics Evaluation and Research said in a safety communication. The strain found was identical to the one found in the two patients.