Non-FDA Approved Treatments with Exosome Therapies May Result in Serious Adverse Drug Events

December 10, 2019

The FDA is raising public awareness about reports of non-FDA approved treatments with exosome therapies which may result in serious adverse drug events.

What are Exosomes?

Exosomes are extracellular vesicles that are believed to mediate intracellular communication. They are currently being investigated in a variety of potential roles for drug delivery and as treatments for certain diseases. Exosomes have been studied for many years but the biological significance and effects of exosomes remains largely unknown.

The Issue

There are reports that certain clinics in Nebraska and possibly other states, are offering exosome treatments for a variety of diseases that have not received FDA approval. As a result, there have been multiple reports of serious adverse drug events experienced by patients who were treated with these products. Any treatment with an exosome would require FDA review and approval. At this time, the FDA has not approved any exosome products.

Recommendations

The FDA is encouraging patients who are offered exosome therapy to confirm that they will be receiving an FDA approved product to reduce the risk of inappropriate treatment with non-approved substances.

The drug safety alert can be read in its entirety on the FDA website Exit Disclaimer: You Are Leaving www.ihs.gov .

Report adverse events to the MedWatch program as recommended in the Indian Health Manual and include “IHS” in the reporter section (section G).

Instructions for reporting can be found online at the NPTC Pharmacovigilance website.