Products found to contain undeclared medicines
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The United States: Be Inspired: Public Notification - Undeclared Ingredients Sibutramine and Phenolphthalein |
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FDA is advising consumers not to purchase or use Be Inspired. FDA laboratory analyses confirmed that Be Inspired contains sibutramine. Sibutramine is a controlled substance that was removed from the US market in October 2010 for safety reasons. This product poses a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and can present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This product can also interact in life-threatening ways with other medications a consumer may be taking.
Laboratory analyses also confirmed that Be Inspired 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.”
Be Inspired is a product promoted and sold for weight loss on various websites, including www.beinspirednaturally.com, 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/../ucm370932.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Friday, October 11, 2013
Issued at HKT 12:00 |
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