Products found to contain undeclared medicines
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| The United States: Bella Vi Insane Amp’d and Bella Vi Amp’d Up: Public Notification - Undeclared Ingredients Sibutramine and Phenolphthalein |
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FDA is advising consumers not to purchase or use Bella Vi Insane Amp’d or Bella Vi Amp’d Up. FDA laboratory analyses confirmed that Bella Vi Insane Amp’d and Bella Vi Amp’d Up contain sibutramine. Sibutramine is a controlled substance that was removed from the US market in October 2010 for safety reasons. These products pose 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. These products can also interact in life-threatening ways with other medications a consumer may be taking.
Laboratory analyses also confirmed that Bella Vi Insane Amp’d and Bella Vi Amp’d Up contain 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.”
Bella Vi Insane Amp’d” and “Bella Vi Amp’d are promoted for weight loss and sold on various websites, including www.pureedgenutrition.com1 and www.newedgenutrition.com2, as well as in retail stores.
Consumers should stop using these products immediately and throw them 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/../ucm370930.htm
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/ Friday, October 11, 2013
Issued at HKT 12:00 |
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