Responding to the rising popularity of “anti-aging” plasma infusions from young adults, the U.S. Food and Drug Administration (FDA) has warned consumers that the practice has not been approved by the regulatory agency and is potentially unsafe, given the residual risks of infection and other complications.
Many establishments located in several states have started offering infusions of plasma obtained from young donors – charging up to thousands of dollars per infusion – for a variety of conditions. However, as the agency wrote in a Biologics Safety and Availability Communication, “there is no proven clinical benefit of the infusion of plasma from young donors in the prevention of conditions such as aging or memory loss or for the treatment of such conditions as dementia, Parkinson disease, multiple sclerosis, Alzheimer disease, heart disease, or post-traumatic stress disorder.”
While there are risks associated with the use of any plasma product, the FDA noted that the services advertised by centers offering “young blood” infusions are not guided by evidence from adequate and well-controlled trials, likely increasing the risks of allergic reactions, transfusionassociated circulatory overload, and infectious disease transmission.
“The administration of plasma for indications other than those recognized or approved by the FDA should be performed by a qualified investigator or sponsor who has an active Investigational New Drug application with the FDA,” FDA Commissioner Scott Gottlieb, MD (who will step down from his role in April) and Center for Biologics Evaluation and Research Director Peter Marks, MD, PhD, said in a statement. “Simply put, we’re concerned that some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors as cures and remedies.”
The FDA did not announce any regulatory or enforcement actions against companies promoting these treatments but noted that it will “continue to closely monitor this issue and take additional steps, as appropriate, along with state and local health departments and blood establishments.”
Source: FDA press announcement, February 19, 2019; FDA Biologics Safety and Availability Communication, February 19, 2019.