Other safety alerts
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| The United States: FDA warns marketers of products labeled as dietary supplements that contain tianeptine for making unproven claims to treat serious conditions, including opioid use disorder |
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The US Food and Drug Administration (FDA) announces that it posted warning letters issued to two companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine, a chemical compound that companies are illegally claiming treats opioid use disorder (OUD), pain and anxiety, and other unlawful and unproven claims. These actions follow reports to FDA of serious adverse events associated with the use of products containing tianeptine.
Tianeptine is approved to treat depression in other countries, and taking it can have significant health effects, including neurologic, cardiovascular, and gastrointestinal signs and symptoms, with some effects mimicking opioid toxicity and withdrawal.
FDA has issued warning letters to Jack B Goods Outlet Store for its Tianaa Red, Tianaa White, and Tianaa Green products and to MA Labs for its Vicaine product. Each of these products is marketed as a dietary supplement and declares tianeptine sodium on the label.
Please refer to the following website in FDA for details:
http://www.fda.gov/NewsEvents/Newsroom/../ucm626349.htm
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Wednesday, Nov 21, 2018
Issued at HKT 16:00
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