Dream Body Slimming Capsule: Public Notification - Undeclared Drug Ingredient

[Posted 01/22/2014]

AUDIENCE: Consumer

ISSUE: FDA is advising consumers not to purchase or use Dream Body Slimming Capsule, a product promoted and sold for weight loss on various websites and in some retail stores. FDA laboratory analysis confirmed that Dream Body Slimming Capsule 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.

BACKGROUND: Dream Body Slimming Capsule is a product promoted and sold for weight loss and sold on various websites, including www.slimbeautyusa.com, and in some retail stores. See the FDA Public Notificiation for additional information, including a product photo.

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.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

[01/21/2014 - Public Notification - FDA]