Be Inspired: Public Notification - Undeclared Ingredients
Audience: Consumer, Health Professional
[Posted 10/10/13]
ISSUE: FDA is advising consumers not to purchase or use Be Inspired. FDA laboratory analyses confirmed that Be Inspired contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. This product poses a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and can present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This product can also interact in life-threatening ways with other medications a consumer may be taking. Laboratory analyses also confirmed that Be Inspired 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.”
BACKGROUND: Be Inspired is a product promoted and sold for weight loss on various websites, and in some retail stores.
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.accessdata.fda.gov/scripts/medwatch/index.cfm
- 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
[10/10/2013 - Public Notification - FDA]
[10/10/2013 - Tainted Weight Loss Products- FDA]
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