Fecal Transplant May Be Linked To Patient’s Death, FDA Warns

The US Food and Drug Administration issued a safety alert on Thursday over the use of fecal transplants after one recipient died

The US Food and Drug Administration issued a safety alert on Thursday over the use of fecal transplants after one recipient died

Now, the FDA is warning that patients hoping to solve their digestive or other health issues with the experimental, unapproved treatment to think twice.

The FDA is warning against possible complications from faecal transplants after one person died and another was sickened. Afterward, both patients developed an infection with a strain of Escherichia coli bacteria that's resistant to multiple types of antibiotics.

Fecal transplants are typically used as a treatment for C. difficile, which per CDC stats kills 29,000 Americans yearly, reports NBC News.

"This was a small trial, but the results suggest that faecal microbiota transplantation may be an alternative to antibiotic therapy in primary C. difficile infection", the authors wrote. In some, a dramatic loss of certain intestinal bacteria causes a serious imbalance that is hard to regain.

The FDA didn't disclose where the stool came from or the organization that provided the transplant.

An unfortunate patient has died after receiving a fecal transplant that contained drug resistant bacteria; the donor stool had not been tested before the procedure according to the FDA.

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Fecal transplants treat severe intestinal disorders by introducing stool from a healthy donor in an attempt to restore a normal balance of bacteria in the intestine. USA Today notes antibiotic-resistant infections kill another 23,000. Other samples from the same donor were screened after the patients got sick and all samples were found to be harboring the same risky germs contracted by the patients, known as multi-drug-resistant organisms. When the fecal transplant is used, relapse rates are significantly reduced.

Though research on using fecal transplants for other health conditions like Crohn's disease, ulcerative colitis, and irritable bowel syndrome (IBS) show promise in some early studies, more research is needed.

In response to these adverse outcomes, the FDA announced new standards requiring researchers in clinical trials to demonstrate proper screening procedures for donor stool. Interest in fecal transplants has also extended into more unexpected realms, like autism.

"The medical community is actively engaged in exploring the potential uses of fecal microbiota for transplantation", he said.

The FDA says the stool was not checked for the presence of drug-resistant bacteria before the procedure. "We therefore want to alert all health care professionals who administer FMT about this potential serious risk so they can inform their patients".

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