WASHINGTON (AP) — U.S. officials have approved the first pharmaceutical-grade version of the so-called fecal transplant procedures that doctors have increasingly used against hard-to-treat intestinal infections.
The Food and Drug Administration on Wednesday approved Rebyota for adults who have trouble fighting off infections with Clostridium difficile, commonly referred to as C. diff, a bacteria that causes nausea, cramping and diarrhea. The infection is particularly dangerous when it reoccurs and is linked to about 15,000 to 30,000 deaths a year.
For more than a decade, some U.S. doctors have used stool samples from healthy donors to treat the condition. The healthy bacteria from donors’ gut has been shown to help recipients fight off C. diff bacteria. The procedure has grown more common as many patients no longer respond to traditional antibiotics.
But the proliferation of stool banks and fecal transplant practitioners across the country has created regulatory headaches for the FDA, which doesn’t traditionally regulate doctors’ medical procedures. The FDA has rarely intervened, provided stool donors are carefully screened for potential infectious diseases.
