La Jiao Shou Shen: Public Notification - Undeclared Drug Ingredient
AUDIENCE: Consumer, Health Professional
ISSUE: FDA is advising consumers not to purchase or use La Jiao Shou Shen, a product promoted and sold for weight loss. FDA laboratory analysis confirmed that La Jiao Shou Shen contains sibutramine and phenolphthalein. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States.
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. Studies have indicated that phenolphthalein presents a cancer-causing risk.
BACKGROUND: La Jiao Shou Shen, a product promoted and sold for weight loss on various websites, including www.slimbeautyusa.com and in some retail stores.
RECOMMENDATION: 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.fda.gov/MedWatch/report.htm
- 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
[06/10/2014 - Public Notification - FDA]