FDA Cracks Down on Unauthorized Use of Plasma Treatments for Aging, Other Illnesses
In the seventeenth century, Hungarian Countess Elizabeth Bathory bathed in the blood of young women she murdered in order to sustain her beauty. Blood, albeit more freely given, continues to be an attractive tool for some who want to stave off the effects of age.
Individuals have been using plasma infusions from young donors as a way to maintain a young and healthy look, but now the U.S. Food and Drug Administration (FDA) is warning against the practice. On Tuesday, FDA Commissioner Scott Gottlieb said the agency has become aware of some medical practices in several states offering infusions of plasma from young donors to stave off aging effects, as well as other conditions, such as dementia, Parkinson’s disease, multiple sclerosis, Alzheimer’s disease, heart disease or post-traumatic stress disorder.
Gottlieb said there is no evidence that supports the use of plasma for these conditions and warned that there is no regulatory safety oversight of these infusions being offered. Gottlieb said people are falling prey to “unscrupulous actors touting treatments of plasma from young donors as cures and remedies”
“We have significant public health concerns about the promotion and use of plasma for these purposes. There is no proven clinical benefit of infusion of plasma from young donors to cure, mitigate, treat, or prevent these conditions, and there are risks associated with the use of any plasma product,” Gottlieb said in a statement.
Plasma is the liquid portion of the blood and contains proteins that help clot blood and can be used for the management of bleeding and clotting abnormalities. Plasma is recognized to have many benefits, but is not recognized to treat conditions such as aging or memory loss, or other diseases like Alzheimer’s or Parkinson’s disease. These plasma treatments being used in these clinics, Gottlieb said, have not gone through FDA testing in order to determine safety or therapeutic benefit. Because of that, Gottlieb said the use of these products should not be assumed to be safe or effective. Gottlieb said the regulatory agency discourages consumers from pursuing these kinds of therapies outside of a clinical trial setting that is under appropriate oversight.
“Moreover, reports we’re seeing indicate that the dosing of these infusions can involve administration of large volumes of plasma that can be associated with significant risks including infectious, allergic, respiratory and cardiovascular risks, among others,” Gottlieb said.
One of the practices that Gottlieb was referring to has halted its plasma infusions since the FDA issued its warning on Tuesday. Monterey, California-based Ambrosia announced on its website that it had halted patient treatments. Prior to the FDA’s announcement, as CNN reported, the Ambrosia website touted the use of plasma infusions as a medical treatment for a variety of issues.