FDA warns about possible SARS-CoV-2, COVID-19 transmission with FMT
The FDA issued a safety alert for the use of fecal microbiota transplantation and the possible risk for transmission of the SARS-CoV-2 virus.
According to the safety alert, various studies have shown SARS-CoV RNA and the SARS-CoV-2 virus present in stools of infected patients, demonstrating that the virus may be transmitted by an FMT.
The FDA noted that the clinical use of FMT, whether used in a study under an investigational new drug application on file with the FDA or under the FDA’s enforcement discretion policy, may potentially transmit the virus. Per the FDA, precautions needed for any use of FMT with stool donated before December 1, 2019 to prevent serious adverse event from SARS-CoV-2 include:
Screen donor with questions directed at identifying donors who may currently or were recently infected with SARS-CoV-2;
Test donors or donor stool for SARS-CoV-2;
Develop exclusion criteria for donors and donor stool based on screening and testing; and
Informed consent with information about the potential for SARS-CoV-2 transmitted via FMT and FMT prepared from stool from donors who are asymptomatic for COVID-19.