[Posted 04/11/2014]

AUDIENCE: Consumer

ISSUE: FDA is advising consumers not to purchase or use Lite Fit USA. FDA laboratory analysis confirmed that Lite Fit USA 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.

These products may also interact, in life-threatening ways, with other medications a consumer may be taking.

BACKGROUND: Lite Fit USA is promoted and sold for weight loss on various websites, including www.herbsultimate.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

[04/11/2014 - Public Notification - FDA]