TOPIC: Fecal Microbiota for Transplantation: Safety Alert - Additional Safety Protections Pertaining to Monkeypox Virus AUDIENCE: Patient, Health Professional ISSUE: The FDA is informing health care providers and patients of the potential risk of transmission of monkeypox virus through fecal microbiota for transplantation (FMT) products and that FDA has determined that additional safety protections are needed. Recent studies have documented the presence of monkeypox virus DNA in rectal swabs and/or stool samples from infected individuals. One study reports detection of monkeypox virus DNA in rectal swabs from three individuals who reported no symptoms of monkeypox disease, including two individuals who had viable monkeypox virus isolated from rectal swabs. This information suggests that monkeypox virus may be transmitted through FMT products, although the risk of such transmission is unknown. Although there is an available test for detection of monkeypox virus DNA from swab samples taken directly from a lesion, at this time, there is limited information on the availability and sensitivity of direct testing of stool for monkeypox virus. For more information about this alert, click on the red button "Read Alert" below. BACKGROUND: Since May 2022, an outbreak of monkeypox disease has been ongoing in multiple countries, including the United States. In the United States, monkeypox is thought to be spreading primarily through close contact with an infected, symptomatic individual. RECOMMENDATIONS: FDA is advising that clinical use of FMT has the potential to transmit monkeypox virus. Due to the potential for serious adverse events to occur, FDA has determined that additional protections are needed for any investigational use of FMT, whether used as part of a study under an Investigational New Drug Application (IND) on file with the FDA or otherwise, if it involves stool donated on or after March 15, 2022. These additional protections are as follows: - Donor screening with questions directed at identifying donors who are at high risk for monkeypox, may be currently infected with monkeypox virus, or may have been recently infected with monkeypox virus;
- Development of criteria for exclusion of donors and donor stool based on donor screening; and
- Informed consent that includes information about the potential for transmission of monkeypox virus via FMT, including FMT prepared from stool from donors who are asymptomatic for monkeypox.
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