ISSUE: FDA laboratory analyses of the product were found to contain undeclared Sibutramine, which is used as an appetite suppressant for weight loss. The FDA has not approved the product as a drug; therefore, the safety and effectiveness of the product is unknown. 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.
BACKGROUND: The product was sold and distributed nationwide via the internet at www.shapingbeauty.com
RECOMMENDATION: Consumers are advised to return the product to the company’s address in Southampton, PA.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems 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
Related MedWatch alert:
[01/13/2011 - Celerite Slimming Capsules]