The Food and Drug Administration is discouraging people from being infused with young blood, a procedure that’s becoming increasingly common but hasn’t been proven to have medical benefits.
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The procedure works like it sounds. People are infused with blood plasma donated from young people. Some clinics claim the procedure works like a fountain of youth to reverse aging and memory loss or even treat diseases like dementia, Parkinson’s disease, multiple sclerosis, Alzheimer’s, heart disease or post-traumatic stress disorder.
Companies typically charge thousands of dollars for the treatments. That concerns the FDA, which says these infusions are “unproven and not guided by evidence from adequate and well-controlled trials.”
“Simply infusing plasma is not a benign intervention and should not be used in such cavalier fashion,” FDA Commissioner Scott Gottlieb told CNBC in a phone interview Tuesday.
New treatments must undergo numerous studies to demonstrate whether they’re safe and effective. The FDA reviews and scrutinizes the data before determining whether treatments can enter the market.
Young blood infusions have not gone through this testing. The FDA does not recognize plasma to treat aging, memory loss or other diseases. Therefore, consumers should not assume them to be safe or effective, Gottlieb said.
“We have a lot of public health concerns. This is not an appropriate use of plasma,” he said.
In addition to there being “no compelling clinical evidence on its efficacy,” the FDA says there’s no information on the appropriate dosing. The agency is concerned with how much young plasma these clinics are pumping into patients. Large volumes of plasma can be associated with “significant risks,” including infections, allergies and respiratory and cardiovascular reactions, Gottlieb said.
The agency may pursue enforcement actions against companies offering these infusions, a process that can take months. It’s starting with a warning to consumers because the agency’s has immediate concerns, Gottlieb said.