The U.S. Food and Drug Administration (FDA) has warned against the use of plasma transfusions from young donors to alleviate or treat the symptoms of multiple sclerosis or other diseases, noting such transfusions have no proven clinical benefit and carry known health risks associated with their use.
Plasma is the liquid component of blood, containing proteins that help in clotting, and can be used to treat bleeding disorders and cases of trauma.
But its use in transfusions as a means of treating conditions ranging from multiple sclerosis, dementia, Alzheimer’s, Parkinson’s, heart disease and post-traumatic stress disorder are of concern, the FDA said in issuing its statement of Feb 19.
“We have significant public health concerns about the promotion and use of plasma for these purposes,” the FDA statement reads. “[W]e’re alerting consumers and health care providers that treatments using plasma from young donors have not gone through the rigorous testing … [necessary] to confirm the therapeutic benefit of a product and to ensure its safety.”
Scott Gottlieb, the FDA’s commissioner, and Peter Marks, director of its Center for Biologics Evaluation and Research, jointly issued the statement cautioning healthcare providers and the public that plasma infusions — being done at “a growing number of clinics” in several U.S. states — are not an FDA-approved or recognized treatment for aging, memory loss, multiple sclerosis, or other diseases.
FDA-approved treatments largely come through clinical trials overseen by researchers and independent boards, and performed under an investigational new drug (IND) application that helps to ensure patient safety.
“Our concerns regarding treatments using plasma from young donors are heightened by the fact that there is no compelling clinical evidence on its efficacy, nor is there information on appropriate dosing for treatment of the conditions for which these products are being advertised,” the statement notes.
According to the FDA, large volumes of plasma might be also be needed for such transfusions and that volume can pose significant risks, including allergic reactions, infections, and heart and respiratory problems.
The agency also expressed concern that such transfusions could discourage patients from taking medications or other treatments known to be safe and effective for their condition.
According to the agency, some “establishments” across the country are recommending young donor plasma infusions and “touting” them “as cures and remedies,” while sometimes “charging thousands of dollars.” The FDA advises patients to consult with their treating physician before opting for any treatment to confirm that it is approved for use, meaning its safety and effectiveness have been demonstrated.
“Simply put, we’re concerned that some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors,” the FDA statement reads.
It also asks that patients who have undergone a plasma transfusion report any ill effects to its MedWatch program, which tracks adverse events related to treatments.