Patient dies after receiving faecal transplant

pharmafile | June 17, 2019 | News story | Sales and Marketing Adverse Event, E.Coli. AMR, FDA, faecal transplant, pharma 

A person has died after experiencing an adverse event related to a faecal transplant.

The FDA has warned that two immunocompromised patients developed invasive infections caused by multi drug resistant bacteria, after receiving a faecal transplant.

The patients were infected with extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E.coli) after receiving faecal microbiota for transplantation (FMT) 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.

Both patients then developed antibiotic resistant E.Coli infections. One of the patients subsequently died.

FMT is an experimental treatment Clostridium difficile, a bacterial infection which causes severe diarrhoea.

“While we support this area of scientific discovery, it’s important to note that FMT does not come without risk,” said Dr Peter Marks, director of FDA’s Center for Biologics Evaluation and Research.

“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.”

Louis Goss

Related Content

FDA approves first oral antiviral to treat adult patients with COVID-19

The US Food and Drug Administration (FDA) has announced that it has approved the oral …

ZOLL remedē System receives FDA approval for sleep apnoea treatment

ZOLL Medical Corporation has announced that it has received approval from the US Food and …

Artivion receives FDA PMA approval of PerClot; transfers designation to Baxter

US cardiac and vascular surgery company Artivion has announced that the US Food and Drug …

Latest content