Since May 2022, multiple countries have witnessed an outbreak of monkeypox disease, with the probable spread primarily through close contact with an infected, symptomatic individual. If, and the extent to which monkeypox virus transmits through feces or from asymptomatic infected individuals is yet unclear.

The Food and Drug Administration (FDA) warns health care providers and patients of the potential risk of monkeypox virus transmission through fecal microbiota for transplantation (FMT) products. It has also highlighted the need for additional safety protections, which are as follows:

• Screening donors for monkeypox at high risk, infected with monkeypox virus currently, or recently infected with monkeypox virus;

o It must also include retrospective screening for using FMT prepared from stool donated between March 15, 2022, and the date of the forthcoming implementation of updated donor screening for monkeypox.

• Developing criteria for excluding donors and donor stool based on donor screening; and
• Informed consent containing information about the potential for monkeypox virus transmission via FMT, including FMT prepared from stool from donors who are asymptomatic for monkeypox.

In July 2013, the FDA issued guidance regarding the IND requirements for using FMT products to treat C. difficile infection in patients who have not responded to standard therapies, which directed treating physicians to obtain adequate consent for using FMT from the patient or their legally authorized representative. The consent should include at least a statement that says using FMT to treat C. difficile is investigational and also discusses its potential risks.

U.S Food and Drug Administration [Internet].Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to Monkeypox Virus; 22 Aug 2022.