FDA Issues Safety Alert On Fecal Microbiota Transplants

Federal regulators indicate that fecal microbiota transplants can cause serious infections, and have already resulted in at least six serious illnesses, including two deaths.

In a safety alert issued on March 12, the FDA warned about that side effects of fecal transplants may include serious adverse events through transmission of pathogenic organisms.

Fecal transplants contaminated with deadly bacterium have already resulted in two deaths and four hospitalizations. The six infections were caused by enteropathogenic Escherichia coli (EPEC) and Shigatoxin-producing Escherichia coli (STEC) and occurred after patients underwent fecal transplants. All six patients fell ill after undergoing fecal transplants to treat Clostridium difficile infections not responsive to standard therapies.

During a fecal transplant, pills of freeze-dried pieces of stool from screened donors are given to transplant recipients. They can be swallowed, delivered through colonoscopy, or delivered via enema.

Fecal transplants are used to replace or replenish good bacteria in the intestinal tract. It is considered experimental, but thought to improve food breakdown, hormone imbalance and immune response. Some studies have indicated fecal transplants can cure 80% to 90% of Clostridium difficile infections, which are highly resistant to antibiotics. However, the FDA now warns that fecal transplants carry the risk of serious side effects due to transmission of pathogenic organisms.

The two patients who died received fecal product from the same donor, who was associated with the STEC infection. Both patients had chronic medical conditions and received fecal transplants to treat C. diff.

The two patients developed diarrhea after the transplant, but their stool was not tested for STEC. It is not conclusive as to whether the STEC infections lead to the patient’s deaths.

The stool for the transplants was supplied by a stool bank company based in the United States. The stool bank provides fecal microbiota product manufactured from pre-screened donors to healthcare providers and researchers.

The FDA issued a guidance document regarding fecal transplants in 2013 and later issued a safety warning in 2019. The safety warning  indicated that fecal transplants carried risks of drug-resistant infections. The warning came after one person died and another become seriously ill following fecal transplants.

In a study published in November 2019, researchers found there was a need for enhanced donor screening for fecal transplants to avoid drug-resistant bacteria or other life-threatening bacteria from spreading to recipients.

Researchers also warned that treating doctors should get consent for the use of fecal transplants from the patient. The consent should emphasize the transplant is an investigative treatment and carries serious risks.

The FDA recommends patients considering fecal transplants talk to their doctor about the benefits and the risks of fecal transplants before undergoing the process.

Doctors and patients should report adverse events or side effects related to fecal transplants to the FDA’s MedWatch Adverse Event Reporting Program.