Friday, 23 August, 2019

Poop transplant claims one life, prompts FDA warning

FDA warns of one patient death from a fecal transplant FDA issues safety alert over fecal transplants after patient’s death
Anna Jefferson | 17 June, 2019, 16:01

A warning from the U.S Food and Drug Administration (FDA) was issued yesterday after a patient died due to receiving a fecal transplant that contained drug-resistant bacteria. After the detection of these events, stored preparation of FMT from the stool donor were tested and found to be positive for ESBL-producing E coli which was identical to the organism isolated from the patient.

Unlock this article by subscribing to STAT Plus and enjoy your first 30 days free! The procedure is done using one of four methods: colonoscopy, enema, nasogastric (NG) tube or "poop pills" which contain frozen bacteria from the donor sample. Both individuals received stool from the same donor, who was not screened for disease-causing bacteria before the procedure.

Also, when fecal microbiota transplants are used, doctors need to have adequate informed consent from the patient, the FDA said. Though some questionable evidence might support this claim, it does not take into account significant safety concerns.

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One report by the CDC found that in the USA, at least two million individuals acquire drug-resistant infections, which results in death in at least 23,000 cases. The agency notes that the donor stool used in these 2 individuals were not tested for ESBL-producing gram-negative organisms prior to use in the FMT. At-home fecal transplants join other harmful practices spread online like consuming chlorine dioxide - aka industrial bleach.

"Recently, faecal microbiota transplantation has been shown to be effective in the treatment of recurrent C. difficile infection", a study in the New England Journal of Medicine said in 2018. In this context, fecal transfer has emerged as promising approach to restoring a healthy gut microbiome in order to treat diseases of the gut. The agency also works to strike a balance between assuring patient safety and facilitating access to unapproved treatments for unmet medical needs. However, the FDA warns that it has not been approved yet and that it is highly experimental. The FDA said it was halting fecal transplant clinical trials until researchers can prove to the FDA that they have measures in place to verify the fecal matter is free of deadly bacteria. We've become aware of infections with multi-drug resistant organisms after patients received investigational FMT, including one patient death. "We therefore want to alert all health care professionals who administer FMT about this potential serious risk so they can inform their patients".

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