[Posted 07/08/2011]

 

AUDIENCE: Consumer

ISSUE: FDA is advising consumers not to purchase or use “Slim Forte Slimming Capsules,” “Slim Forte Slimming Coffee,” and “Botanical Slimming Soft Gel. FDA laboratory analysis confirmed that these products contain sibutramine. Sibutramine is a controlled substance that was removed from the U.S. market in October 2010 for safety reasons. These products pose 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. These products may also interact in life threatening ways with other medications a consumer may be taking.

BACKGROUND: Slim Forte Slimming Capsules, Slim Forte Slimming Coffee, and Botanical Slimming Soft Gel are products marketed for weight loss, sold on various websites and distributed by InterCharm, Inc. This notification is to inform the public of a growing trend of products marketed as dietary supplements or conventional foods with hidden drugs and chemicals.

RECOMMENDATION: Consumers should stop using these products immediately and throw them 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

[07/08/2011 - Public Notification - FDA]

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