The U.S. Food and Drug Administration (FDA) is warning consumers, physicians, and health care providers that infusions of plasma from young donors for the treatment of normal aging or diseases such as Parkinson’s or Alzheimer’s are not approved and have not undergone the agency’s rigorous testing for efficacy and safety.
As a result, such a method — also used for multiple sclerosis, heart disease, or post-traumatic stress disorder — should not be regarded as safe or effective.
“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,” read a statement from FDA Commissioner Scott Gottlieb, MD, and Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
The benefits of plasma, the liquid portion of the blood, are well-known, particularly in trauma or for abnormal blood clotting. The FDA-recognized Circular of Information for the Use of Human Blood and Blood Components details indications for safe and effective plasma use, where the treatment’s benefits outweigh its risks. But even in such cases plasma infusion still has risks, such as allergies and transfusion-related circulatory overload, resulting in pulmonary edema (swelling) and difficulty breathing.
Besides a lack of clinical evidence, the FDA’s concerns also include the lack of data on appropriate dosing for the indications for which these treatments are being marketed in several states. Also, reports indicate that the infusion of large volumes of plasma may lead to infections and cardiovascular problems.
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The agency cautions that plasma infusions for indications other than those approved should be done by a qualified investigator or sponsor with an active investigational new drug (IND) application with the agency. Clinical trials must be performed under an IND to make sure the treatment is safe.
“We strongly discourage consumers from pursuing this therapy outside of clinical trials under appropriate institutional review board and regulatory oversight,” Gottlieb and Marks stated. “We support sound, scientific research and regulation of medical treatments.”
They added, “We’re concerned that some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young as cures and remedies.” The statement mentioned reports of clinics charging thousands of dollars for therapies with unproven benefits, with potential harmful effects and which have not been guided by well-controlled clinical studies.
Also, promoting plasma in such cases could discourage patients from being treated with appropriate treatments that may be available, the agency said.
The FDA is considering taking “regulatory and enforcement actions against companies that abuse the trust of patients” and jeopardize their health” by using uncontrolled manufacturing processes or promoting therapies with no evidence of safety or efficacy.
If considering the use of plasma infusions for unapproved indications, the FDA strongly urges patients to consult with their health care providers to confirm whether the agency has reviewed the treatment. Patients should ask the clinical investigator for the IND number and a copy of the FDA-issued communication acknowledging the IND.
Patients and physicians should report any adverse events associated with plasma administration to the FDA’s MedWatch program. The agency continues to monitor this issue, along with state and local health departments, as well as blood establishments.