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June 13, 2019: FDA Issues Fecal Transplant Warning After Patient Dies From Multi-Drug Resistant Bacterial Infection

FDA Fecal Transplant Warning

On June 13, 2019, the FDA warned patients and healthcare professionals of the potential risk for serious or life-threatening infections with the use of fecal microbiota for transplantation (FMT). The warning came after the FDA learned of bacterial infections, including one death, due to the transmission of multi-drug resistant organisms (MDROs) from the use of investigational FMT.

Fecal microbiota transplantation, commonly referred to as a “fecal transplant,” is used to treat patients with Clostridium difficile (C. diff) infections that do not respond to standard therapy. A fecal transplant involves the transfer of stool from a healthy donor to the gastrointestinal tract of a patient for the treatment of recurrent C. diff colitis. The bacteria contained in the stool from the healthy donor can help restore the balance of bacteria in the gastrointestinal tract of the patient.

Multi-drug Resistant Infections Caused By Investigational FMT Prompts FDA Fecal Transplant Warning

The FDA reported that two immunocompromised adults, who both received fecal transplants prepared from the stool of the same donor, developed infections caused by drug resistant Escherichia coli (E.coli). One of the individuals died. The donor stool and resulting FMT used to treat these individuals were not tested for drug-resistant bacteria prior to the transplant. According to the FDA, after these infections occurred, stored preparations of FMT from this stool donor were tested and found to be positive for drug-resistant E. coli identical to the drug-resistant E. coli strain isolated from the two patients.

Fecal Transplant Information for Health Care Providers and Patients

Currently, FMT has not been approved by the FDA for any use, however, the director of FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks, stated that the agency works to “strike a balance between assuring patient safety and facilitating access to unapproved treatments for unmet medical needs.”

FDA guidance directs treating doctors to obtain consent for the use of FMT from the patient or his or her legally authorized representative. The agency stated “consent should include, at a minimum, a statement that the use of FMT to treat C. difficile is investigational and a discussion of its potential risks. FDA is informing members of the medical and scientific communities and other interested persons of the potential risk of transmission of MDROs by FMT and the resultant serious adverse reactions that may occur. Patients considering FMT to treat C. difficile infection should speak to their health care provider to understand the potential risks associated with the product’s use.

Additional patient protection measures for the investigational use of FMT include:

  • Donor screening with questions that specifically address risk factors for colonization with MDROs, and exclusion of individuals at higher risk of colonization with MDROs.
  • MDRO testing of donor
  • About C Diff

    Clostridium difficile is a type of bacterium that can cause diarrhea and colitis (inflammation of the colon). According to the CDC, C. diff is estimated to cause almost half a million illnesses in the United States each year. For more information regarding C. difficile and your legal rights, please see C Diff Lawsuit.

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