The FDA issued a warning after a patient died after undergoing a fecal microbiota transplant procedure.
What you should know:
1. The transplanted fecal matter was contaminated with drug-resistant bacteria. Another person who received the transplant is also sick.
2. Both patients had weakened immune systems and received stool from the same donor.
3. The FDA said the stool was not tested for beta-lactamase, a bacteria-producing enzyme.
FDA Center for Biologics Evaluation and Research director Peter Marks, MD, PhD, said: "While we support this area of scientific discovery, it's important to note that FMT does not come without risk. … 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."
Read the entire release, here.