Products found to contain undeclared medicines
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| The United States: Public Notification: Lean Body Extreme contains hidden drug ingredients sibutramine, desmethyl sibutramine, phenolphthalein, and sildenafil |
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The Food and Drug Administration is advising consumers not to purchase or use Lean Body Extreme, a product promoted and sold for weight loss on various websites and in retail stores. FDA laboratory analysis confirmed that Lean Body Extreme contains sibutramine, desmethyl sibutramine, phenolphthalein, and sildenafil.
Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking. Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States. Studies indicate that it presents a cancer-causing risk. Sildenafil is the active ingredient in the FDA approved prescription drug Viagra, used to treat erectile dysfunction (ED). This undeclared ingredient 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/ResourcesForYou/../ucm435632.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Friday, February 27, 2015
Issued at HKT 13:00
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