Monday, 10 February 2020

Multidrug Antimicrobial Resistance Testing and Fecal Transplant Therapy Risks

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


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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