Public Notification: “Acai Berry Soft Gel ABC” Contains Undeclared Drug Ingredient[October 18, 2011] The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Acai Berry Soft Gel ABC,” a product for weight loss sold on various websites and in some retail stores.
FDA laboratory analysis confirmed that “Acai Berry Soft Gel ABC” contains sibutramine. Sibutramine is a controlled substance that was removed from the U.S. 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. This product may also interact in life threatening ways with other medications a consumer may be taking.
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 this product 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
Please refer to the links below for more information: