Products found to contain undeclared medicines
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| The United States: Public Notification: New You Contains Hidden Prescription Ingredient Sibutramine and Phenolphthalein |
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The Food and Drug Administration (FDA) is advising consumers not to purchase or use New You, a product promoted and sold for weight loss and sold on various websites and in some retail stores. FDA laboratory analysis confirmed that New You contains sibutramine. Sibutramine is a controlled substance that was removed from the US 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. These products may also interact, in life-threatening ways, with other medications a consumer may be taking. Laboratory analysis also confirmed that New You contains phenolphthalein. Phenolphthalein was an ingredient in some over-the-counter (OTC) laxative products until 1999, when FDA reclassified the ingredient as “not generally recognized as safe and effective” after studies indicated that it presented a potential cancer-causing (carcinogenic) risk.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/ResourcesForYou/../ucm391460.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Thursday, April 03, 2014
Issued at HKT 15:00
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