The transplants have come into increasing use to treat severe intestinal orders and sometimes work quickly in patients wasting away. But the procedure to use stool from a healthy donor to restore the normal balance of bacteria and other organisms in the intestine is considered experimental by the FDA.
Stat: FDA Warns Of One Patient Death From A Fecal Transplant
The Food and Drug Administration announced Thursday that at least one person has died after a fecal microbiome transplant transmitted drug-resistant bacteria. The FDA said one other person was also sick from the transplant; both people had weaker-than-normal immune systems and received stool from the same donor. The stool was not tested for a type of bacteria that produces an enzyme called beta-lactamase. (Sheridan, 6/13)
The New York Times: Fecal Transplant Is Linked To A Patient’s Death, The F.D.A. Warns
As a result, the agency is halting a number of clinical trials until the researchers conducting them can demonstrate that they have procedures in place to screen donated stool for dangerous organisms, said Dr. Peter Marks, director of the agency’s Center for Biologics Evaluation and Research. In an interview, he did not specify how many trials would be suspended, but said it was “not just a few.” Fecal transplants have come into increasing use to treat severe intestinal disorders, particularly an infection caused by a bacterium called Clostridium difficile, which can be deadly and tends to occur in hospitalized patients who have been heavily treated with antibiotics. (Grady, 6/13)
USA Today: Fecal Transplant: FDA Warns About Drug-Resistant Bacteria C. Difficile
Two adults with comprised immune systems who received a transplant from the same donor developed invasive infections caused by Escherichia coli (E.coli) that produced extended-spectrum beta-lactamase (ESBL), the FDA said. The donor stool was not tested for the drug-resistant bacteria prior to the procedure, the FDA noted. After the patients got sick, a stored sample from the stool donor was tested and found to contain the E. coli present in the two patients. (Yancey-Bragg, 6/13)
CNN: FDA Issues Safety Alert Over Fecal Transplants After Patient’s Death
The FDA will now require that all stool samples used in transplants be tested for drug-resistant microorganisms. All donors will also need to be screened for potential drug-resistant infections. According to the US Centers for Disease Control and Prevention, “antibiotic resistance is one of the biggest public health challenges of our time.” The CDC estimates that at least 2 million Americans develop drug-resistant bacterial infections every year, and at least 23,000 die. (Kounang, 6/13)
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Source : Kaiser Health