Magic Slim: Public Notification - Undeclared Drug Ingredient
ISSUE: FDA is advising consumers not to purchase or use Magic Slim, a product promoted and sold for weight loss and sold on various websites and in some retail stores. FDA laboratory analysis confirmed that Magic Slim 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 Magic Slim contains phenolphthalein. Phenolphthalein was an ingredient in some over-the-counter (OTC) laxative products until 1999, when FDA reclassified the ingredient as “not generally recognized as safe and effective” after studies indicated that it presented a potential cancer-causing (carcinogenic) risk.
BACKGROUND: Magic Slim is a product promoted and sold for weight loss and sold on various websites, including www.slimbeautyusa.com, and in some retail stores. See the FDA Public Notificiation for additional information, including a product photo.
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
[01/21/2014 - Public Notification - FDA]