“FDA warns against fecal transplants after one patient contracted a drug-resistant infection and DIED.
Two people got experimental fecal transplant procedures and developed drug-resistant E. coli infections, the Food and Drug Administration said Thursday, June 13, 2019.
One of the patients died as a result of the infection.
The donor samples used to treat the patients – for undisclosed conditions – were not tested for superbugs.
Currently, fecal transplants are not approved by the FDA, but it gives occasional approval for ‘investigational’ uses of the ‘poop transfer’ to treat C diff.
Now, the agency will require all donated stool to be tested for superbugs.
Clinical trials have suggested that ‘poop transplants,’ as they are colloquially referred to, may be effective in treating C diff infections which can cause diarrhea and even become life-threatening if the colon becomes – and remains – inflamed.
On the other hand, some people have attempted ‘DIY’ fecal transplants at home.
The theory behind the cringe-inducing procedures is that imbalances in the bacterial population of an individual’s gut can throw off their digestive health. Although the FDA has not approved the treatment protocol, it did issue guidance directing any physician intending to perform a fecal transplant to at least have patients sign waivers and consent forms stating that they’re having the fecal transfer done to treat C diff.
And in light of the two recent, disastrous attempts to use the procedure, the FDA will now require documentation that the donor’s stool has undergone MDRO testing – screening for any bacteria that might be resistant to multiple antibiotics – prior to transfer.
Neither donated fecal sample transferred to the two patients that developed drug-resistant E. coli infections underwent such testing, according to the FDA’s statement.
The agency is not aware of bacterial infections caused by multi-drug resistant organisms (MDROs) that have occurred due to transmission of a MDRO from use of investigational FMT,’ or fecal microbiota for transplantation,’ the agency said.”
By NATALIE RAHHAL DEPUTY HEALTH EDITOR FOR DAILYMAIL.COM
PUBLISHED: 09:36 EDT, 14 June 2019 | UPDATED: 09:36 EDT, 14 June 2019
www.nytimes.com/2019/06/13/health/fecal-transplant-fda.html
www.cnbc.com/2019/06/13/fda-issues-warning-after-patient-dies-following-fecal-transplant.html
