FDA Warns Consumers of Hidden Drug Ingredients in Certain Xcelerated Weight Loss Products

On Friday, July 22^nd , the FDA published three public notifications warning consumers of hidden drug ingredients that are present in various Xcelerated Weight Loss products.  Two of the company’s products, Xcelerated Weight Loss Charged Up and Xcelerated Weight Loss Turbo Charge, have been found to contain sibutramine, a controlled substance, removed from the market for safety reasons in October 2010.  In its notice, the FDA states that these products pose 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.”  The Agency also notes the products could also have life-threatening interactions with other medications that consumers may be taking.

FDA’s third warning concerns Xcelerated Weight Loss Ultra Max, which has been found to contain phenolphthalein and sildenafil based on a laboratory analysis conducted by the FDA.  According to the Agency’s notice, studies involving phenolphthalein indicate that it presents a cancer-causing risk in previous studies.  Among its approved indications, Sildenafil is the active ingredient in Viagra, the FDA-approved drug indicated for the treatment of erectile dysfunction (ED).  In its public notification, FDA states that “this undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.”

FDA is advising consumers not to purchase or use these products, which are available online and in select retail stores.  In addition, FDA encourages patients and healthcare professionals to report any adverse events or side effects associated with the use of these products to its MedWatch Safety Information and Adverse Event Reporting Program.

Are you in the process of developing a dietary supplement? Do you have a supplement that you’re looking to verify is compliant with all FDA regulations? We can help you achieve a successful interaction with FDA.  To learn more about our services and how we can help you, contact us today.