Beware Young-Donor Plasma Infusions, FDA Warns

Consumers should be wary of establishments offering infusions of plasma obtained from young human donors, according to a warning issued by the U.S. Food and Drug Administration (FDA).

Clinics in several states market young-donor plasma infusions as an anti-aging therapy or as treatment for a variety of diseases, from multiple sclerosis to post-traumatic stress disorder – at a cost of up to thousands of dollars per infusion. However, there are no proven clinical benefits for these conditions. In fact, plasma infusions can raise the risk of infection or allergic, respiratory, and cardiovascular problems.

While no specific companies have been named, the FDA indicated that it will consider taking enforcement actions, such as sending warning letters demanding corrective actions, against companies that promote such treatments.

In a statement, FDA Commissioner Scott Gottlieb (who announced March 5 that he will step down from his role in April) and Center for Biologics Evaluation and Research Director Peter Marks, MD, PhD, said “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.”

Source: The Washington Post, February 19, 2019; FDA press release, February 19, 2019.