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新 聞 及 資 訊   The United States: Public Safety Notification on Exosome Products (EnglishOnly)   The United States Food and Drug Administration (FDA) announces to inform the public, especially patients, health care practitioners, and clinics, of multiple recent reports of serious adverse events experienced by patients in Nebraska of the United States 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. FDA is carefully assessing this situation along with the federal and state partners. There are currently no FDA-approved exosome products. Certain clinics across the country, 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 – that is simply untrue. 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. The clinics currently offering these products outside of FDA’s review process are taking advantage of patients and flouting federal statutes and FDA regulations. This ultimately 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 these recent reports of adverse events. Health care professionals and consumers should report to the FDA any adverse events related to exosome products or any other unapproved product. Patients considering treatment with exosome products in the United States should: - Ask if the FDA has reviewed the treatment. They also can ask the clinical investigator to give the FDA-issued Investigational New Drug Application (IND) number and the chance to review the FDA communication acknowledging the IND. They can ask for this information before getting treatment and follow up with the personal health care provider to confirm the information. - Request the facts and ask questions if they don’t understand. To participate in a clinical trial that requires an IND application, they must sign a consent form that explains the experimental procedure. The consent form also identifies the Institutional Review Board (IRB) that assures the protection of the rights and welfare of human subjects. They should make sure understanding the entire process and known risks before signing. They also can ask the study sponsor for the clinical investigator’s brochure, which includes a short description of the product and information about its safety and effectiveness. Please refer to the following website in FDA for details: http://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-exosome-products In Hong Kong, there is currently no registered pharmaceutical product containing exosome Ends/ Saturday, December 7, 2019 Issued at HKT 15:15