The FDA is warning consumers to avoid using or purchasing the herbal weight loss product New You after a laboratory analysis discovered undeclared sibutramine and phenolphthalein.
Sibutramine, a Schedule IV substance, was voluntarily withdrawn from the market in October 2010 following evidence supporting potentially serious cardiovascular adverse effects. Sibutramine may pose a significant risk for patients with prior coronary artery disease, congestive heart failure, arrhythmias, or stroke. Phenolphthalein, a compound previously found in many over-the-counter (OTC) laxatives, is no longer approved for use after concerns of carcinogenicity arose. Currently, phenolphthalein is classified by the FDA as “not generally recognized as safe and effective.”
New You has been sold on various websites and in some retail stores.
For more information call (855) 543-3784 or read the FDA Safety Alert.