On December 6, 2019, the FDA warned the public, especially patients, health care practitioners, and clinics, of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes. These reports were brought to the FDA’s attention by the Centers for Disease Control and Prevention, among others, and the agencies worked with the Nebraska Department of Health and Human Services.
As a general matter, exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products under the Public Health Service Act and the Federal Food Drug and Cosmetic Act and are subject to premarket review and approval requirements.
There are currently no FDA-approved exosome products. Certain clinics across the USA, including some that manufacture or market violative “stem cell” products, are now also offering exosome products to patients. They deceive patients with unsubstantiated claims about the potential for these products to prevent, treat or cure various diseases or conditions. They may claim that they these products do not fall under the regulatory provisions for drugs and biological products, which is false.
The FDA warns that clinics currently offering these products outside of FDA’s review process are taking advantage of patients and flouting federal statutes and FDA regulations, which puts at risk the very patients that these clinics claim to want to help, by either delaying treatment with legitimate and scientifically sound treatment options, or worse, posing harm to patients, as evidenced by the recent reports of adverse events.
The FDA advises consumers that the FDA does not have oversight of treatments done in other countries, and the FDA typically has little information about foreign establishments or their products. The FDA warns consumers to be cautious: “If you’re considering an exosome product in a country that may not require regulatory review of clinical studies, it may be hard to know if the experimental treatment is reasonably safe.”
The FDA requests that health care professionals and consumers report any adverse events related to exosome products or any other unapproved product to the FDA’s MedWatch Adverse Event Reporting program.
The Nebraska Incidents
Dr. Maureen Tierney, head of the health care-associated infections program in the Nebraska Department of Health and Human Services, determined that exosmome therapy was the source of some people in Nebrsaka becoming ill after receiving the product derived from placentas. Fewer than five people became ill, all within the past two months, and all are recovering, but some were very sick. The investigation is ongoing.
Dr. Tierney stated, “this particular product from this particular manufacturer is no longer present in Nebraska,” but urged anyone who has had similar experiences with such products to contact a health care provider, who can reach out to the state.
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