FDA warns against young donor plasma infusions promoted to treat a variety of conditions

FDA is cautioning consumers about establishments that are offering infusions of plasma from young donors that claim to treat the effects of a number of conditions, ranging from normal aging and memory loss to dementia, multiple sclerosis, and post-traumatic stress disorder.

FDA is cautioning consumers about establishments that are offering infusions of plasma from young donors that claim to treat the effects of a number of conditions, ranging from normal aging and memory loss to dementia, multiple sclerosis, and post-traumatic stress disorder. "We have significant public health concerns about the promotion and use of plasma for these purposes," said FDA Commissioner Scott Gottlieb, MD, and Peter Marks, MD, PhD, director of FDA's Center for Biologics Evaluation and Research. "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." In an alert issued Tuesday, FDA warned that the treatment using plasma from young donors have not gone through FDA's rigorous safety and efficacy testing. "As a result, the reported uses of these products should not be assumed to be safe or effective," said Gottlieb and Marks. "We strongly discourage consumers from pursing this therapy outside of clinical trials under appropriate institutional review board and regulatory oversight."