[7-9-2021] The Food and Drug Administration is advising consumers not to purchase or use Cholestene, a product promoted and sold for cholesterol management on various websites and possibly in some retail stores.
FDA laboratory analysis confirmed Cholestene contains lovastatin, the active ingredient in the FDA-approved prescription drug Mevacor, used to treat patients with high blood cholesterol levels. FDA approval of Mevacor is restricted to use under the supervision of a licensed health care professional. This undeclared drug ingredient may cause serious side effects when combined with other medications. People with liver dysfunction or taking medicines that impair liver metabolism are at greater risk of muscle injury, which can appear as muscle pain, muscle weakness, fatigue, and dark colored urine.
Health care professionals and patients should report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online MedWatch Online Voluntary Reporting Form, or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Note: This notification is to inform the public of products marketed as dietary supplements or conventional foods with hidden drug ingredients 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: