The US Food and Drug Administration (FDA) has released a statement regarding the safety of plasma infusions. It claims it has seen a rise in the number of establishments in the US offering infusions of plasma from young donors to purportedly treat the effects of a variety of conditions. This treatment is being used to treat a number of conditions from normal ageing and memory loss to more serious conditions including multiple sclerosis (MS).
In the statement the FDA said: “We have significant public health concerns about the promotion and use of plasma for these purposes. 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.”
These 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. “The reported uses of these products should not be assumed to be safe or effective. We strongly discourage consumers from pursing this therapy outside of clinical trials under appropriate institutional review board and regulatory oversight,” they claimed.
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 recognised, especially in trauma settings or in patients whose blood is unable to clot due to medications or certain illnesses.
The statement said: “The FDA-recognised Circular of Information for the Use of Human Blood and Blood Components, published by AABB, lists recognised indications for which the administration of plasma is safe and effective; these are included in the FDA’s safety communication. For those patients receiving a plasma product for a recognised use, the benefits of treatment have been determined by the agency 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.
“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. Plasma is not FDA-recognised or approved to treat conditions such as normal aging or memory loss, or other diseases like Alzheimer’s or Parkinson’s disease. Moreover, reports we’re seeing indicate that the dosing of these infusions can involve administration of large volumes of plasma that can be associated with significant risks including infectious, allergic, respiratory and cardiovascular risks, among others.
“Simply put, we’re 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. We strongly urge 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: MS-UK, 28/02/19