Shou Fu Ti Tun Guo Xiang Xing Jian Fei Jiao Nang: Public Notification - Undeclared Drug Ingredient
Audience: Consumer
Also known as:
- “收腹æ臀果香型å‡è‚¥èƒ¶å›Š ”(translates – Abdomen Hips Fruit Flavored Slimming Capsules)
- “Сокращать живот и повышать 3ад” (translates – Reducing Belly and Lifting the Buttocks).
[Posted 09/17/2013]
ISSUE: FDA is advising consumers not to purchase or use “收腹æ臀果香型å‡è‚¥èƒ¶å›Š ”or “Shou Fu Ti Tun Guo Xiang Xing Jian Fei Jiao Nang” (translates – Abdomen Hips Fruit Flavored Slimming Capsules) also known as “Сокращать живот и повышать 3ад” (translates – Reducing Belly and Lifting the Buttocks).
FDA laboratory analysis confirmed that Shou Fu Ti Tun Guo Xiang Xing Jian Fei Jiao Nang contains sibutramine. 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.
Laboratory analysis also confirmed that Shou Fu Ti Tun Guo Xiang Xing Jian Fei Jiao Nang 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.”
BACKGROUND: Product is promoted and sold for weight loss on various websites, including www.instantslim.org, and in some retail stores. See the FDA Public Notification for product photo and additional information.
RECOMMENDATION: Consumers should stop using this product immediately and throw it away. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[09/17/2013 - Public Notification - FDA]
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