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MARCH 28, 2020 -- There is a risk for transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, through fecal microbiota transplants (FMTs). Additional safety measures are needed to reduce the risk, the US Food and Drug Administration (FDA) says in a safety alert.
Recent studies have found SARS-CoV-2 RNA and/or SARS-CoV-2 virus in stool of infected individuals, suggesting the virus may be transmitted by FMT, "although the risk of such transmission is unknown," the agency explains.
Testing nasopharyngeal specimens from stool donors for the virus may not be widely available, and there is limited information on the availability and sensitivity of testing stool for the virus, the FDA notes.
For now, the FDA recommends the following actions regarding any use of FMT that involves stool donated after December 1, 2019:
Screening donors by asking questions designed to identify donors who may be currently infected or who may have recently been infected with SARS-CoV-2;
Testing donors and/or donor stool for SARS-CoV-2, as feasible;
Developing criteria for screening and testing so as to exclude donors and donor stool;
Informing FMT recipients about the potential for transmission of SARS-CoV-2 via FMT, including FMT prepared from stool from donors who are asymptomatic for COVID-19.
The FDA says it will provide more guidance on this issue as more information becomes available.
Adverse events or side effects related to the use of FMT products should be reported to the FDA's MedWatch program.
Earlier this month, the FDA warned that FMT poses a risk for serious or life-threatening adverse events because of transmission of pathogenic organisms, as reported by Medscape Medical News.
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