Vitaccino Coffee: Public Notification - Undeclared Drug Ingredient
ISSUE: FDA is advising consumers not to purchase or use Vitaccino Coffee, a product promoted and sold for weight loss. FDA laboratory analysis confirmed that Vitaccino Coffee contains sibutramine, 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. Sibutramine may also 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: Vitaccino Coffee is sold on various websites and in some retail stores.
RECOMMENDATION: Do not purchase or use Vitaccino Coffee.
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
[03/19/2014 - Public Notification - FDA]
Related FDA Safety Information
[03/19/2014 - Tainted Weight Loss Products - FDA]