In a warning to consumers on Tuesday, the FDA said consumers should be cautious about establishments offering infusions of plasma obtained from young human donors with the claim that the infused plasma will prevent aging to memory loss.
At a cost of up to thousands of dollars per infusion, the FDA said these establishments, located in several different states, are currently offering infusions of plasma with no proven clinical benefit.
For instance, a startup called Ambrosia, which has clinics in New York and California, offers such treatments for $8,000 for one liter and $12,000 for two liters, although scientists called the pay-to-participate trial a scam.
FDA also notes establishments claiming that blood transfusions can prevent not only 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,” the FDA said. “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.”
In a note to health care providers, the agency also said 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.”
First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.
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