[10-24-2019] The Food and Drug Administration is advising consumers not to purchase or use CholesLo, a product promoted and sold for lowering cholesterol on various websites, including www.choleslo.com, and possibly in some retail stores.
FDA laboratory analysis confirmed that CholesLo contains undeclared lovastatin. Lovastatin is the active ingredient in Mevacor® and its generic counterparts, which are FDA-approved drugs used to treat patients with primary hypercholesterolemia. This undeclared drug ingredient may cause serious side effects when combined with other medications.
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, or 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.
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