Authors: Martha Powell, Future Science Group
The US FDA has issued a safety communication warning over the risk of serious infections caused by multidrug-resistant organisms in investigational Fecal Microbial Transplant (FMT).
The warning comes after two immunocompromised adults who received FMT developed invasive infections due to the transmission of multidrug-resistant organisms. The infection led to the death of one of these patients.
Following these two serious adverse reactions, the FDA has determined that certain donor screening and stool testing protections are necessary for any investigational use of FMT. In addition, the FDA hopes the communication will alert healthcare professionals about the potential risk of drug-resistant organism transmission in this procedure, and the serious health outcomes that might occur.
Peter Marks, Director of FDA’s Center for Biologics Evaluation and Research, commented: “The medical community is actively engaged in exploring the potential uses of FMT. 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.”
FMT is currently used to treat C. difficile under investigational new drug (IND) regulations in patients who have not responded to standard therapies. The FDA will now exercise enforcement discretion regarding the IND requirements for the use of FMT, and they also reminded healthcare professionals that adequate informed consent should be obtained from the patients in these cases.
The FDA encourages health care professionals and patients to report any adverse events or side effects to the FDA’s MedWatch Adverse Event Reporting program.
Marks concluded: “While we support this area of scientific discovery, it’s important to note that FMT does not come without risk. We’ve become aware of infections with multidrug-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. Today’s safety communication underscores the importance of why new therapies are thoroughly studied to ensure the benefits of taking them outweigh the risks to patients, and we will continue to aggressively monitor clinical trials to ensure patients are protected when safety concerns arise.”
You might also like: