March 24, 2020

FDA: Safety Alert on transmission risk of SARS-CoV-2 virus in fecal microbiota

By: Judy Mathias

Editor's Note

The Food & Drug Administration on March 23 issued a Safety Alert to inform healthcare providers and patients of the potential risk of transmission of SARS-CoV-2 virus by the use of fecal microbiota for transplantation (FMT), and that the agency has determined that additional safety protections are needed.

Because recent studies have documented the presence of SARS-CoV-2 ribonucleic acid (RNA) and /or SARS-CoV-2 virus in the stool of infected patients, the FDA is advising that the clinical use of FMT has the potential to transmit SARS-CoV-2, whether used as part of an Investigational New Drug study on file with the FDA or under the FDA’s enforcement discretion policy.

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To address this risk, the FDA says stool used for FMT should have been donated before December 1, 2019, and that protections are needed for use of FMT donated after December 1, including:

  • Donor screening with questions to identify those who may be currently or recently infected with SARS-CoV-2
  • Testing donors and/or donor stool for SARS-CoV-2
  • Development of exclusion criteria for donors and donor stool
  • Informed consent that included information about the potential for transmission of SARS-CoV-2 via FMT.

The FDA is in the process of notifying IND holders of the risk of transmission of SARS-CoV-2 via FMT and that additional safety protections are needed.


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