FDA halts U.S. poop transplants pending further review
The Food and Drug Administration has ordered clinicians to stop transplanting healthy fecal matter from one patient to another until the agency has had a chance to review and test the procedure.
According to the Omaha World-Herald, the therapy is used to fight the antibiotic-resistant bug Clostridium difficile, or C. diff.
In FMT therapy, a small amount of healthy stool is introduced to the gut of a patient suffering from C. diff, a multidrug resistant germ that can take hold in a person’s digestive tract when they are prescribed antibiotics, for instance. C. diff is notoriously hard to cure and manifests in the form of persistant, sometimes bloody diarrhea. Left unchecked, it can cause serious dehydration, damage to the colon and even death.
When stool containing healthy bacteria is introduced into the system, many patients are finally getting relief from chronic C. diff infections, which physicians point to as reason enough to continue the procedure.
Earlier this month, the FDA held a public forum about FMT therapy at the National Institute of Health in Bethesda, Maryland. The purpose of the forum, said the agency, was to “provide a forum for the exchange of information, knowledge, and experience” about FMT.
The agency said in a press release, that “the efficacy of this intervention has not yet been demonstrated in controlled clinical trials. Such controlled trials are needed to demonstrate the safety and effectiveness of FMT products for C. difficile infection.”
Furthermore, said the release, “FMT is also being considered as a treatment for inflammatory bowel disease, obesity, and other disorders, and controlled trials are needed in these settings as well.”
Some doctors consider it an annoyance that the FDA is attempting to regulate the new procedure, and argue that bureaucratic hurdles will only make it harder for patients who need the therapy to obtain it.
The FDA has designated Fecal Microbiota for Transplantation (FMT) therapy an “investigational new drug,” meaning that physicians who apply to the federal board may perform the procedure, but some doctors feel that their access to a promising treatment is being overly complicated by the new rules.
“Unfortunately, it puts up a major regulatory hurdle and barrier for doctors,” Dr. Mark Rupp, chief of the division of infectious diseases at the University of Nebraska Medical Center told the Omaha World-Herald.
The director of the University of Iowa’s infectious diseases division, Dr. Dan Diekema, also said, “I’m concerned about it because I’m worried that it will limit people’s access to this critically important procedure.”
[Woman explaining stomach pain to doctor via Shutterstock.com]
[Ed. note: This article after publication was added to provide additional links.]