Following
the death of one patient and another falling seriously ill (reported in June
2019), the U.S. Food and Drug Administration (FDA) has called for greater
controls over fecal transplants and the introduction of microbial pathogen
screening. The patients became infected with a multi-drug resistant bacterial
infection.
To
review the implications of this, Tim Sandle has written an article for American
Pharmaceutical Review.
Here
is an extract:
Fecal
transplants (or ‘fecal bacteriotherapy’) appear to have a high success rate.
The technique aims to restore the balance between good bacteria and bad
bacteria in the colon, and there is clinical evidence that this process reduces
the incidence of specific pathogens (particularly C. difficile) and such therapies are showing signs of success
against certain metabolic diseases. However, the June 2019 warning issued by
the FDA highlights a lack of control around screening for other pathogens and
it appears that it is possible to transfer high levels of a different pathogen
into a patient in addition to the pathogen that is intended to be treated.
Hence, if the goal for fecal bacteriotherapy is to transition to the status of
a consistently produced and manufactured pharmaceutical preparation then
standardized microbiological quality control testing is required, both to
assess the numbers and concentrations of beneficial bacteria that are required
and in order to screen for the presence or absence of pathogens that might
cause patient harm.
The
reference is:
Sandle,
T. (2019) Multidrug Antimicrobial Resistance Testing and Fecal Transplant
Therapy Risks, American Pharmaceutical
Review, 22 (6): 116-118
See:
https://www.americanpharmaceuticalreview.com/Featured-Articles/518551-Multidrug-Antimicrobial-Resistance-Testing-and-Fecal-Transplant-Therapy-Risks/?catid=6262
Posted by Dr. Tim Sandle,
Pharmaceutical Microbiology
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