FDA Issues Warning About Misuse of Young Donor Plasma Infusions

Scott Gottlieb, MD, FDA Commissioner

Scott Gottlieb, MD

The FDA has issued a joint statement from its commissioner, Scott Gottlieb, MD, and Peter Marks, MD, PhD, the director of the agency’s Center for Biologics Evaluation and Research, regarding young donor plasma infusions being offered at a variety of establishments as a treatment for conditions for which its benefits are unproven.¹

The conditions in question range from standard aging and memory loss issues, to conditions such as dementia, Parkinson disease, multiple sclerosis, Alzheimer disease, heart disease, and post-traumatic stress disorder.

“We have significant public health concerns about the promotion and use of plasma for these purposes,” the pair stated. “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.”

“Today, we’re alerting consumers and health care providers that 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 reported uses of these products should not be assumed to be safe or effective. We strongly discourage consumers from pursuing this therapy outside of clinical trials under appropriate institutional review board and regulatory oversight,” they added.

The Circular of Information for the Use of Human Blood and Blood Components, which is published by the AABB, the joint effort of the American Red Cross, America’s Blood Centers, and the Armed Services Blood Program, is recognized by the FDA as an authoritative list of the acceptable indications for which the administration of plasma is safe and effective.²

The list includes the management of preoperative or bleeding patients, patients undergoing massive transfusion, patients who are taking warfarin who are bleeding or need to undergo an invasive procedure before anticoagulation effects could be reversed, for transfusion or plasma exchange in those with thrombotic thrombocytopenic purpura, for the management of patients with selected coagulation factor deficiencies, and for the management of patients with rare plasma protein deficiencies when recombinant products are not available.³

“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,” Gottlieb and Marks stated. “Plasma is not FDA-recognized or approved to treat conditions such as normal aging or memory loss, or other diseases like Alzheimer or Parkinson 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.”

Gottlieb and Marks expressed their concern that patients are being “preyed upon by unscrupulous actors touting treatments of plasma from young donors as cures and remedies,” noting that there are reports of these bad actors charging patients thousands of dollars for these infusions. The promotion of plasma for these purposes, they warn, may also discourage those with these serious health conditions from seeking proper medical care, thus causing further damage from their illness in addition to the known and unknown risks associated with this treatment.

“As a growing number of clinics offer plasma from young donors and similar therapies, we want to encourage consumers considering treatments to ask their health care providers to confirm that the FDA has reviewed any treatment that is investigational,” they said. “You also can ask the clinical investigator to give you the FDA-issued IND number and to provide a copy of the FDA communication acknowledging the IND. We encourage patients to ask for this information before receiving treatment. Furthermore, we urge patients and their health care providers to report any adverse events related to treatment with plasma from young donors for aging or related indications to the FDA’s MedWatch Adverse Event Reporting program.”

The FDA’s MedWatch Adverse Event Reporting program can be accessed online. Additionally, the agency has offered a list of important safety information about young donor plasma infusions for profit on its website.³

REFERENCES

1. Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., cautioning consumers against receiving young donor plasma infusions that are promoted as unproven treatment for varying conditions [press release]. Silver Spring, MD: FDA; Published February 19, 2019. fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631568.htm. Accessed February 19, 2019.

2. Circular of Information for the Use of Human Blood and Blood Components. AABB website. Published October 2017. aabb.org/tm/coi/Documents/coi1017.pdf. Accessed February 19, 2019.

3. Important Information about Young Donor Plasma Infusions for Profit [press release]. Silver Spring, MD: FDA; Published February 19, 2019. fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm631374.htm. Accessed February 19, 2019.