ISSUE: The Food and Drug Administration (FDA) is advising consumers not to purchase or use Sit and Slim II.
FDA laboratory analysis confirmed that Sit and Slim II 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.
Laboratory analysis also confirmed that Sit and Slim contains phenolphthalein. Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer-causing risk.
BACKGROUND: Sit and Slim II is a product promoted and sold for sexual enhancement on various websites and in some retail stores. See the Public Notification for a product photo.
RECOMMENDATION: Health care 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.
[10/10/2014 - Public Notification - FDA]