FDA issues safety alert over fecal transplants after patient’s death
WASHINGTON — The US Food and Drug Administration issued a safety alert on Thursday over the use of fecal transplants after one recipient died.
The investigational treatment has not been approved by the FDA. Known as fecal microbiota for transplantation, it has been used to treat cases of Clostridium difficile, or C. diff, that haven’t responded to traditional antibiotic treatments. C. diff is a bacterium that causes diarrhea and inflammation of the colon.
Fecal transplant utilizes the stool of a healthy person to transfer good bacteria into the intestines of an infected person.
The FDA said that two people with weakened immune systems who received transplant samples from the same donor developed another antibiotic-resistant infection, a form of E. coli. The donor sample was not tested for the bacteria before use.
The FDA will now require that all stool samples used in transplants be tested for drug-resistant microorganisms. All donors will also need to be screened for potential drug-resistant infections.
According to the US Centers for Disease Control and Prevention, “antibiotic resistance is one of the biggest public health challenges of our time.” The CDC estimates that at least 2 million Americans develop drug-resistant bacterial infections every year, and at least 23,000 die.