AUDIENCE: Patient, Health Professional
ISSUE: Because of the potential risk of transmission of SARS-CoV-2 via Fecal Microbiota for Transplantation (FMT), FDA has determined that additional protections are needed for any investigational use of FMT, whether under an Investigational New Drug Application (IND) on file with the FDA or under FDA’s enforcement discretion policy.
BACKGROUND: The rapidly evolving global pandemic of COVID-19 necessitates that FDA provide updated information to the March 23, 2020, Safety Alert. The safety alert informed health care providers and patients of the potential risk of transmission of SARS-CoV-2 by FMT. SARS-CoV-2 is the virus that causes the respiratory disease, COVID-19.
RECOMMENDATION: FDA has already notified all IND holders of the need for additional protections. These additional protections include:
No clinical use of FMT product manufactured from stool donated on or after December 1, 2019, until additional screening and testing procedures and changes to the informed consent process are implemented for such stool donations as described below:
- Stool donor screening, including an assessment of whether, since December 1, 2019, the donor was diagnosed with laboratory-confirmed SARS-CoV-2 infection, experienced symptoms of COVID-19 (e.g., fever, cough, shortness of breath) not explained by another diagnosis, or was exposed to a suspected or confirmed case of COVID-19 or SARS-CoV-2 infection.
- In any instances of suspected or confirmed SARS-CoV-2 infection or exposure as described above, exclusion of the donor from further donations and exclusion from clinical use of any FMT product manufactured from stool donated by the affected donor beginning 4 weeks prior to the suspected or confirmed SARS-CoV-2 infection or exposure.
- Testing of the stool donation or stool donor for SARS-CoV-2 virus or RNA.
- Testing approaches might include testing upper respiratory specimens (e.g., nasal swabs) or other specimens (e.g., rectal swabs or stool donations).
- If SARS-CoV-2 is detected, exclusion of the donor from further donations and exclusion from clinical use of any FMT product manufactured from stool donated by the affected donor beginning 4 weeks prior to the first positive test.
- As part of the informed consent process, conveying to the FMT recipient that healthy, asymptomatic stool donors may potentially be infected with SARS-CoV-2, describing the testing approach and other strategies used to mitigate the risk of SARS-CoV-2 transmission, and advising the FMT recipient of the limitations of testing and risk mitigation strategies.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form or submit by fax to 1-800-FDA-0178
[04/09/2020 - Safety Alert - FDA]