A new medical procedure has been put into action, however, has recently received enormous backlash due to its uncertain outcomes. This week, the U.S. Food and Drug Administration (FDA) has issued a safety warning over fecal transplants following the death of one patient after a procedure, while another patient became deathly ill. Early Morning Thursday, the FDA posted to its website, announcing the alert, saying that the use of fecal microbiota for transplantation (FMT) carries the “potential risk of serious or life-threatening infections.”
According to the FDA’s report, the two immunocompromised patients developed E. coli infections before receiving fecal transplants from the same donor. They also added, “The donor stool and resulting FMT used in these two individuals were not tested for ESBL-producing gram-negative organisms before use.”
“After these adverse events occurred, stores preparations of FMT from this stool donor were tested and found to be positive for ESBL-producing E. coli identical to the organisms isolated from the two patients,” they noted.
Despite the fecal transplant not being approved by the FDA, it is still allowed to be used in clinical trials. The reasons for the operation is not yet clear, but it typical cases the procedure is used to treat C. difficile colitis, a complication of antibiotic therapy. According to the 2013 study, fecal transplant is more effective at treating C. difficile colitis than oral antibiotics and usually prevented any recurrences.
Patients over the age of 65 and have chronic illnesses, may be at higher risk for having a critical infection. Initially, Diagnosis is based on a stool DNA test that identifies the organism.
Usually, the transplant is done through a colonoscopy or by nasoduodenal tube. According to the Johns Hopkins Division of Gastroenterology and Hepatology, as the colonoscope is removed from the patient, the donor feces is delivered through the colonoscopy into the patient’s colon.
Since the devasting outcomes, the FDA is urging patients who are considering fecal transplant to treat C. difficile to do their research and speak to their health care provider or specialist about the considerable risk that is linked to the procedure. They are also urging donors to answer truthfully to specific questions during screening about the risk factors. Donors stool will be testing using MDRO now mandated by the FDA.
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