FDA Warns About Young Donor Plasma Infusions Promoted As Unproven Treatment For Varying Conditions

The FDA Commissioner and the Director of the FDA’s Center for Biologics Evaluation and Research issued a statement on February 19, 2019 cautioning consumers against receiving young donor plasma infusions that are promoted as unproven treatment for varying conditions. The conditions range from normal aging and memory loss to serious diseases like dementia, Parkinson’s disease, multiple sclerosis, Alzheimer’s disease, heart disease, or post-traumatic stress disorder.

The FDA has “significant public health concerns” about the promotion and use of plasma for these purposes because 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. Treatments using plasma from young donors have not gone through the rigorous testing that the FDA normally requires in order to confirm the therapeutic benefit of a product and to ensure its safety. As a result, the FDA warns that reported uses of these products should not be assumed to be safe or effective and the FDA strongly discourages consumers from pursing this therapy outside of clinical trials under appropriate institutional review board and regulatory oversight.

What Is Plasma?

Plasma is the liquid portion of the blood. It contains proteins that help clot blood and can be used for the management of bleeding and clotting abnormalities. The benefits of plasma have long been recognized, especially in trauma settings or in patients whose blood is unable to clot due to medications or certain illnesses. For those patients receiving a plasma product for a recognized use, the benefits of treatment have been determined by the FDA to outweigh its risks. But even under such recognized uses, plasma administration is not without risks. The more common risks are allergic reactions and transfusion associated circulatory overload and less common risks include transfusion related acute lung injury or transfusion associated circulatory overload and infectious disease transmission.

The FDA is concerned that some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors as cures and remedies. Such treatments have no proven clinical benefits for the uses for which these clinics are advertising them and are potentially harmful. There are reports of bad actors charging thousands of dollars for infusions that are unproven and not guided by evidence from adequate and well-controlled trials. The promotion of plasma for these unproven purposes could also discourage patients suffering from serious or intractable illnesses from receiving safe and effective treatments that may be available to them. The FDA “strongly urge[s]” individuals to consult their treating physicians prior to considering the use of such products for aging indications or for the treatment of conditions such as dementia, Parkinson’s disease, multiple sclerosis, Alzheimer’s disease, heart disease or post-traumatic stress disorder given the known and unknown risks associated with their use.

Source

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This entry was posted on Friday, March 15th, 2019 at 5:28 am. Both comments and pings are currently closed.

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