Risk of Monkeypox Transmission Through Fecal Transplant

8/24/22 — The FDA is informing healthcare providers and patients of the potential risk of transmission of monkeypox virus through fecal microbiota for transplantation (FMT) products. 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. FMT may be used to treat C. difficile infection in patients who have not responded to standard therapies.

Additional protections include:

• 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.

Read the FDA safety alert.