Products found to contain undeclared medicines
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| The United States: News Release: FDA warns consumers not to use Zi Xiu Tang Bee Pollen capsules |
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The U.S. Food and Drug Administration (FDA) is warning consumers to immediately stop using Zi Xiu Tang Bee Pollen, marketed as a product for weight loss and body reshaping. The product contains at least one potentially harmful active pharmaceutical ingredient that is not listed on the product's label.
The FDA has tested multiple Zi Xiu Tang Bee Pollen products from various distributors in the United States. All products have been found to contain one or both of the following undeclared drug ingredients sibutramine and phenolphthalein. Sibutramine – 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. Phenolphthalein – a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer-causing risk.
Zi Xiu Tang Bee Pollen is manufactured by Guangzhou Zi Xiu Tang Biotechnology Co., Ltd. in Guangdong Province, China. It is offered for sale on the Internet, and it can be found in various retail stores, spas and fitness centers. In addition, licensed health care professionals have promoted the product.
The FDA has received dozens of adverse event reports, including many serious cardiac issues, associated with the use of Zi Xiu Tang Bee Pollen. Reports have included heart palpitations, tachycardia (increased heart rate), suicidal thoughts, chest pain, diarrhea, anxiety, insomnia, increased blood pressure and seizure. Consumers who have experienced any negative side effects while taking this product should consult a health care professional.
Please refer to the following website in FDA for details:
http://www.fda.gov/NewsEvents/Newsroom/../ucm392163.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Tuesday, April 08, 2014
Issued at HKT 14:00
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