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Safety Alert Due To Marketing Of Unapproved Stem Cell And Exosome Products

January 23, 2020,

The National Agency for Food and Drug Administration and Control has been informed by US FDA of illegal “stem cell” products 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. There are currently no FDA-approved exosome products.

Exosomes is used to treat diseases and conditions in humans which are regulated as drugs and biological products under the Public Health Service Act and the Federal Food Drug and Cosmetic Act of USFDA and are subject to premarket review and approval requirements.

Any healthcare facility currently offering these products outside of FDA’s review process and NAFDAC`s approval is taking advantage of patients and ultimately puts patients at risk 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.

RECOMMENDATION:

NAFDAC implores all importers, wholesalers and retailers to immediately stop the importation, distribution, and use of the unapproved product.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Patients and healthcare providers are advised to report adverse events and quality problems they experienced using these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLLS FREE from all networks) or via pharmacovigilance@nafdac.gov.ng

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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