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Fecal transplants |
On
June 13, 2019, the Food and Drug Administration (FDA) informed health care
providers and patients of the potential risk of serious or life-threatening
infections with the use of fecal microbiota for transplantation (FMT). Bacterial infections caused by multi-drug
resistant organisms (MDROs) have occurred due to transmission of a MDRO from
use of investigational FMT, resulting in the death of one individual.
Because
these serious adverse reactions occurred with investigational FMT, FDA has
determined that additional protections are needed for any investigational use
of FMT. FDA has notified all
Investigational New Drug (IND) holders of these requirements and that they need
to implement these new requirements no later than July 15, 2019.
FDA
has received inquiries from non-IND holders since the release of the June 13,
2019 safety communication, such as those who may be using FMT under enforcement
discretion, regarding the additional screening and testing procedures.
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