[04-02-2014] The Food and Drug Administration (FDA) is advising consumers not to purchase or use New You, a product promoted and sold for weight loss and sold on various websites and in some retail stores.
FDA laboratory analysis confirmed that New You 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 New You 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.
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
Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.
Please refer to the links below for more information:
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