FDA Warns Against Plasma Treatments from Young Donors
February 19, 2019
The U.S. Food and Drug Administration released a statement today warning consumers not to undergo treatments involving plasma obtained from young donors. Early reports of small studies in people with MS and Parkinson’s disease have recently appeared in the press. “We have significant public health concerns about the promotion and use of plasma for these purposes,” notes FDA Commissioner Scott Gottlieb, MD, and Director of the Center for Biologics Evaluation and Research Peter Marks, MD, PHD. “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.”
Plasma is the liquid portion of the blood, and contains proteins that help clot blood and can be used to manage bleeding and clotting abnormalities. There are recognized indications for which the administration of plasma is safe and effective (see the FDA’s safety communication below). But even under such recognized uses, plasma administration is not without risks. Risks include allergic reactions, lung injury, and infectious disease.
Please read the entire FDA statement here
Read the FDA’s safety communication
Multiple sclerosis is an unpredictable disease of the central nervous system. Currently there is no cure. Symptoms vary from person to person and may include disabling fatigue, mobility challenges, cognitive changes, and vision issues. An estimated 1 million people live with MS in the United States. Early diagnosis and treatment are critical to minimize disability. Significant progress is being made to achieve a world free of MS.