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  1. Safety & Availability (Biologics)

Important Information about Young Donor Plasma Infusions for Profit

February 19, 2019

The Food and Drug Administration (FDA) is advising consumers to be cautious about establishments offering infusions of plasma obtained from young human donors with the claim that the infused plasma will treat a variety of conditions ranging from normal aging to memory loss.

Summary of the Issue

Establishments located in several different states are currently offering infusions of plasma, which were obtained from young donors, to individuals at a cost of up to thousands of dollars per infusion for a variety of conditions. There is no proven clinical benefit of the infusion of plasma from young donors in the prevention of conditions such as aging or memory loss, or for the treatment of such conditions as dementia, Parkinson’s disease, multiple sclerosis, Alzheimer’s disease, heart disease, or post-traumatic stress disorder. The dosing of these infusions, which can involve large administered volumes, is also not guided by evidence from adequate and well controlled trials. In addition, the infusion of plasma can be associated with infectious, allergic, respiratory, and cardiovascular risks, among others:

  • Even though blood products are screened for a variety of different infectious agents, there is always a residual risk that the product may contain an infectious agent
  • The infusion of plasma is occasionally associated with serious allergic reactions, including anaphylaxis, which can manifest as hives and airway obstruction
  • Infusion of plasma can occasionally cause transfusion-related acute lung injury
  • In some individuals, particularly those with preexisting heart disease, the infusion of plasma can cause overload of the circulatory system leading to swelling of the body and difficult breathing.

Information for Health Care Providers and Patients

Plasma is the liquid portion of the blood that contains clotting factors, antibodies, and other proteins. The FDA-recognized Circular of Information for the Use of Human Blood and Blood Components published by AABB lists the following indications for the administration of plasma:

  • Management of preoperative or bleeding patients who require replacement of multiple plasma coagulation factors (e.g., liver disease, disseminated intravascular coagulation)
  • Patients undergoing massive transfusion who have clinically significant coagulation deficiencies
  • Patients taking warfarin who are bleeding or need to undergo an invasive procedure before vitamin K could reverse the warfarin effect or who need only transient reversal of warfarin effect
  • Transfusion or plasma exchange in patients with thrombotic thrombocytopenic purpura
  • Transfusion or plasma exchange with selected coagulation factor deficiencies, congenital or acquired, for which no specific coagulation concentrates are available
  • Management of patients with rare specific plasma protein deficiencies, when recombinant products are unavailable.

In patients with one or more of the indications for administration of plasma listed in the FDA-recognized Circular of Information, the benefits of treatment with plasma outweigh its risks. In contrast, plasma is not FDA-approved to treat other conditions such as normal aging or memory loss. Additionally, there have not been any well-controlled studies that show the clinical benefit of the administration of plasma from young donors, and there are associated safety risks. The administration of plasma for indications other than those listed in the FDA-recognized Circular of Information should be performed by a qualified investigator or sponsor who has an active Investigational New Drug application with the FDA.

Reporting Adverse Events

The agency encourages health care professionals and consumers to report any adverse reactions resulting from the administration of plasma to the FDA’s MedWatch program:

 
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