Fecal transplant treatments could infect patients with monkeypox, the U.S. Food and Drug Administration has warned.
Since May, an outbreak of monkeypox has been spreading in multiple countries, including the United States. Nearly 16,000 people in the United States have already been infected with the virus, which is transmitted through close physical contact with symptomatic individuals.
Monkeypox virus DNA has been found in rectal swabs and stool samples from infected people, the FDA said in its alert, which was issued this week.
That includes one study where monkeypox virus was found in three people who reported no symptoms of the disease, the agency said.
“FDA is advising that clinical use of FMT [fecal microbiota for transplantation] has the potential to transmit monkeypox virus,” the alert said.
As a result, the FDA has recommended donor screening for clinical trials involving fecal transplants if the studies involve stool donated on or after March 15, 2022.
Patients should also be informed of the monkeypox risk, the agency added.
Fecal transplants are used as a treatment for persistent Clostridium difficile infections, an opportunistic bacteria that can cause dangerous bouts of diarrhea and inflammation of the colon.
Nearly half a million C. diff infections are reported in the United States each year, according to the U.S. Centers for Disease Control and Prevention. One in 11 people over 65 will die within one month of contracting C. diff in a health care setting.
Johns Hopkins has more about fecal transplants.
SOURCE: U.S. Food and Drug Administration, news release, Aug. 24, 2022