[ad_1]
The United States Food and Drug Administration (FDA) has issued a safety warning for stool transplants after a patient dies from surgery, and another one has become seriously ill. In a safety alert posted Thursday on its website, the FDA said that the use of fecal microbiota for transplantation (FMT) carries a "potential risk of serious or life-threatening infections" .
The FDA said the two immunocompromised patients developed E. coli infection after receiving a stool transplant from the same donor.
MAMMARY IMPLANTS RELATED TO A RARE FORM OF CANCER, BUT THE FDA DECLINES THE PROHIBITION
"The donor stool and the resulting FMT used in these two individuals have not been tested to detect the presence of gram-negative ESBL-producing organisms prior to their use," the FDA noted. "After these adverse events occurred, the preparations of the stores containing FMT from this stool donor were tested and found to be positive for ESBL-producing E. coli identical to the organisms isolated from both patients."
The treatment has not been approved by the FDA, but can be used in a clinical trial.
TEXAS MAN BECOMES THE OLDEST DONOR OF THE NATION AFTER GIVING KIDNEY TO THE NEIGHBOR
Although the reason why patients received stool transplants is unclear, the procedure was used to treat C. difficile colitis, a complication of antibiotic therapy. A study conducted in 2013 showed that stool transplants were more effective in treating C. difficile colitis than oral antibiotics and prevented recurrence.
The procedure is usually performed by a colonoscopy or nasoduodenal tube, according to Johns Hopkins' division of gastroenterology and hepatology. When the colonscope is removed from the patient, the stool of the donor is routed by colonoscopy into the colon.
CLICK HERE TO GET THE FOX NEWS APP
FDA urges patients considering a fecal transplant to treat C. difficile to talk to their health care provider about potential risks associated with the procedure and donors to answer specific questions when screening for risk factors . The FDA also recommends the MDRO test of donor stool.
[ad_2]
Source link