Slim Xtreme Herbal Slimming Capsule: Undeclared Drug Ingredient
ISSUE: FDA laboratory analysis confirmed that "Slim Xtreme Herbal Slimming Capsule" contains sibutramine. Sibutramine is a controlled substance that was withdrawn from the U.S. market in October 2010 for safety reasons.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, and stroke. This product may also interact in life threatening ways with other medications a consumer may be taking.
BACKGROUND: Slim Xtreme Herbal Slimming Capsule is marketed as a product for weight loss sold on various websites and distributed by Globe All Wellness.
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
[05/10/2011 – Public Notification - FDA]