As per FDA two patients
received donated stool that had not been screened for drug-resistant germs,
leading it to halt clinical trials until researchers prove proper testing
procedures are in place.
Both transplants came from the
same donor’s fecal matter. The report does not state whether the fecal material
was given in liquid form as an infusion into the digestive tract or swallowed
as pills.
Other samples from the same
donor were tested after the patients got sick. The samples were found to harbor
the same dangerous germs found in the patients, known as multi-drug-resistant
organisms. They were E. coli bacteria that produced an enzyme called
extended-spectrum beta-lactamase, which makes them resistant to multiple
antibiotics. The stool had not been tested for the germs before being given to
the patients.
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. The idea behind the transplants is to use stool from
a healthy donor to restore the normal balance of bacteria and other organisms
in the intestine, the microbiome.
The FDA on Thursday issued a
warning to researchers that stool from donors in studies of fecal
transplantation should be screened for drug-resistant microbes, and not used if
those were present. It is also warning patients that the procedure can be
risky, is not approved by the agency and should be used only as a last resort
when C. difficile does not respond to standard treatments.
This is especially pertinent
for countries like India, where the patient may be exposed to infection with
drug-resistant bacteria and the source of infection cannot be found. Efforts
should be made to trace the source of infection in all cases of sepsis. This
will help in better management of patients.
Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of
Medical Associations in Asia and Oceania
(CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of
India
Past National President
IMA
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