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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

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system. Symptoms range from numbness and tingling to blindness and paralysis, and there is currently no cure for MS. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. An estimated 1 million people live with MS in the United States. Most people with MS are diagnosed between the ages of 20 and 50, and it affects women three times more than men.


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