If you're planning on getting infused with young blood to fight memory loss and aging, the US Food and Drug Administration would like you to reconsider.
FDA Commissioner Scott Gottlieb and Peter Marks, director of the Center for Biologics Evaluation and Research, warned in a statement Tuesday against getting infused with blood plasma from young donors. Claims that these infusions can help treat conditions such as, , , heart disease and post-traumatic stress disorder haven't been clinically proven, the FDA said.
"We have significant public health concerns about the promotion and use of plasma for these purposes," Gottlieb and Marks said. "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."
The FDA said it's alerting consumers and health care providers that treatments using young blood haven't gone through the appropriate testing to confirm their therapeutic benefit and safety. Therefore, these infusions shouldn't be considered safe or effective, and consumers shouldn't get the infusions beyond clinical trials with an institutional review board and regulatory oversight, it said.
Plasma is the liquid part of blood that contains proteins to help with clotting. It can be used to manage bleeding. Patients whose blood is unable to clot can benefit from plasma, though there are still risks such as allergic reactions.
Plasma infusions from young donors can involve administering large amounts of plasma, which can be linked with infectious, allergic, respiratory and cardiovascular risks, according to the FDA. Some people have charged thousands of dollars for infusions that haven't been proven to be effective, the agency said.
"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," Gottlieb and Marks said. "Such treatments have no proven clinical benefits for the uses for which these clinics are advertising them and are potentially harmful."
The administration said it'll consider taking actions against companies that abuse patients' trust and that endanger their health, whether through their manufacturing conditions or by promoting purported treatments that haven't been proven safe or effective.
Following the FDA's statement, Ambrosia Health, a startup that charged thousands of dollars for plasma infusions from young donors, said on its site that it has stopped patient treatments. The company didn't immediately respond to a request for comment.
People considering plasma treatments should ask their health care provider if the FDA has reviewed a treatment before proceeding, the agency said. It's also asking patients and health care providers to report negative side effects linked to treatments using plasma from young donors, for aging or similar conditions, to the FDA's MedWatch Adverse Event Reporting program.
The FDA said it'll monitor the issue and take appropriate steps with state and local health departments and blood establishments.
First published Feb. 19, 2 p.m. PT.
Update, Feb. 20 at 9:43 a.m.: Adds that Ambrosia Health has stopped patient treatments following the FDA's statement.