Products found to contain undeclared medicines
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| The United States: XZone Premium: Public Notification - Undeclared Drug Ingredient Sildenafil, Tadalafil, and Dapoxetine |
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FDA is advising consumers not to purchase or use XZone Premium, a product promoted and sold for sexual enhancement. FDA laboratory analysis confirmed that XZone Premium contains sildenafil, tadalafil, and dapoxetine. Sildenafil and tadalafil are the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, 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. XZone Premium is sold on various websites and in some retail stores. Consumers should stop using this product immediately and throw it away. Consumers who have experienced any negative side effects should consult a healthcare professional as soon as possible.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm369724.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Wednesday, September 25, 2013
Issued at HKT 14:30 |
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