Important Information about Young Donor Plasma Infusions for Profit

PUBLISHED: Feb 20, 2019
Relevant to: All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) has recently become aware of reports of establishments in several states that are offering infusions of plasma from young donors to purportedly treat the effects of a variety of conditions. The conditions range from normal aging and memory loss to serious diseases like dementia, Parkinson’s disease, multiple sclerosis, Alzheimer’s disease, heart disease or post-traumatic stress disorder. The FDA has significant public health concerns about the promotion and use of plasma for these purposes.

According to the FDA, there is no proven clinical benefit of infusion of plasma from young donors to cure, mitigate, treat, or prevent the above listed conditions, and there are risks associated with the use of any plasma product.

The FDA is alerting consumers and health care providers that treatments using plasma from young donors have not gone through the rigorous testing that the FDA normally requires in order to confirm the therapeutic benefit of a product and to ensure its safety. As a result, the reported uses of these products should not be assumed to be safe or effective.

The FDA strongly discourages consumers from pursing this therapy outside of clinical trials under appropriate institutional review board and regulatory oversight.

Follow the link below for additional information.

Want to read the full alert and receive alert emails?

Browse Additional Alerts