WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) announced that fecal transplant procedures and studies must immediately stop after one transplant patient died and another fell gravely ill from the procedure. The New York Times reported that the procedure is a safe alternative for treating people suffering from Clostridium difficile, which is a bacterial infection commonly suffered by patients who took antibiotics for a long time. Clostridium difficile, more commonly known as c. difficile causes persistent diarrhea in victims. The fecal transplant procedure helps restore good bacteria in the gut. However, the one patient who died and the other patient who fell ill received a fecal transplant from a person who had drug-resistant gut bacteria.
The FDA ordered a stop to all fecal transplant procedures and studies until adequate safeguards are put in place. The safeguards should protect fecal transplant recipients from obtaining fecal matter from a person who has drug-resistant bacteria. The two transplant victims obtained a potentially deadly strain of e. Coli from the procedure. The two sickened patients received fecal matter from the safe donor. The FDA noted that the two people who fell severely ill were already in an immunosuppressed state. The FDA did not say why that was the case, and according to Mentalfloss.com, noted that fecal transplant is not indicated for someone in an immunosuppressed state.
The FDA hopes to balance the needs of sick people who are dying from c. difficile, for whom fecal transplant procedures have proved incredibly useful, with the need to proceed cautiously while the scientists figure out the appropriate screening tests for drug-resistant bacteria found in transplant donors. Fecal transplants are a dangerous medical procedure. The FDA has not approved them to date and considers them to be experimental. Once the new protocols are in place to screen the donor and the fecal matter before transplant, the FDA will likely permit clinical trials to resume.
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