Products found to contain undeclared medicines
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| The United States: Public Notification: Triple MiracleZen Extreme 1750 mg contains hidden drug ingredients sildenafil, tadalafil and dapoxetine |
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The Food and Drug Administration (FDA) is advising consumers not to purchase or use Triple MiracleZen Extreme 1750 mg, a product promoted and sold for sexual enhancement on various websites and in some retail stores.
FDA laboratory analysis confirmed that Triple MiracleZen Extreme 1750 mg contains sildenafil, tadalafil and dapoxetine. Sildenafil and tadalafil, the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, are used to treat erectile dysfunction (ED). These undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Dapoxetine is an active ingredient not approved by FDA, and therefore its safety and efficacy have not been established.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/ResourcesForYou/../ucm479094.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Tuesday, December 29, 2015
Issued at HKT 13:00
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