Treatment with fecal microbiota for transplantation (FMT) may potentially result in SARS-CoV-2 transmission, the virus that causes coronavirus disease (COVID-19), according to the Food and Drug Administration (FDA).
The Agency is alerting healthcare professionals about the potential risk and the need for additional safety precautions after several recent studies revealed the presence of SARS-CoV-2 ribonucleic acid and/or SARS-CoV-2 virus in the stool of infected individuals.
Fecal microbiota transplantation is an experimental therapy used in patients with Clostridioides difficile infection that has not responded to standard treatments. Studies have suggested that the use of fecal microbiota collected from healthy individuals can restore intestinal flora in patients with refractory C. difficile infection.
While the risk of transmission is currently unknown, the information does suggest that it may be possible. Therefore, to minimize risk, stool used for FMT should have been donated before December 1, 2019.
For stool donated AFTER December 1, 2019, the FDA recommends the following protections:
- Donor screening to identify donors who may be currently or recently infected with SARS-CoV-2.
- Donor or donor stool testing for SARS-CoV-2, if possible.
- Developing exclusion criteria based on screening and testing.
- Informing patients about the possibility of transmission, even from FMT prepared from asymptomatic donors.
More information will be relayed to the healthcare community as it becomes available. In the meantime, the FDA encourages healthcare professionals to report suspected adverse events related to FMT administration to the MedWatch Adverse Event Reporting program.
For more information visit fda.gov.