June 13, 2019
The US Food and Drug Administration (FDA) is alerting healthcare providers and patients that fecal microbiota for transplant (FMT) may transmit multidrug-resistant organisms, leading to serious or life-threatening infections.
In a safety communication issued today, the FDA said two immunocompromised adults who received FMT developed invasive bacterial infections caused by extended-spectrum beta-lactamase (ESBL)–producing Escherichia coli. One of the patients died.
The FMT used in these two individuals were prepared from stool obtained from the same donor. The donor stool and resulting FMT used in these two individuals were not tested for ESBL-producing gram-negative organisms prior to use, the FDA noted.
After these infections occurred, stored preparations of FMT from this stool donor tested positive for ESBL-producing E coli identical to the organisms isolated from the two patients.
On the basis of these two cases, the FDA advises that, with any investigational use of FMT, donors be screened with questions that specifically address risk factors for colonization with multidrug-resistant organisms (MDROs). Individuals found to be at higher risk for colonization with MDROs should be excluded.
Risk for Unapproved Therapy
The FDA also advises that donor stool be tested for MDROs, and that stool that tests positive for MDROs be excluded.
"While we support this area of scientific discovery, it's important to note that FMT does not come without risk," Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said in a news release.
"We've become aware of infections with multi-drug resistant organisms after patients received investigational FMT, including one patient death. We therefore want to alert all health care professionals who administer FMT about this potential serious risk so they can inform their patients," said Marks.
"Although FMT is not approved by the FDA for any use, the agency plays a critical role in supporting product development while assessing the risks and benefits to patients of unapproved therapies. The agency also works to strike a balance between assuring patient safety and facilitating access to unapproved treatments for unmet medical needs," he added.
In 2013, the FDA issued guidance in which it stated that it intends to exercise enforcement discretion, under limited conditions, regarding the investigational new drug requirements for FMT used to treat Clostridium difficile infection in patients for whom standard therapies fail.
The guidance regarding FMT requires that treating physicians obtain adequate informed consent, which should include a statement that the use of FMT to treat C difficile is investigational, and that physicians discusss potential risks with patients.
Adverse events associated with FMT should be reported to the FDA's MedWatch Adverse Event Reporting program.