Dietary Supplement Contains Hidden Statin, FDA Warns

The US Food and Drug Administration (FDA) is warning consumers to avoid the dietary supplement Cholestene because it contains lovastatin, the active ingredient in the FDA-approved prescription drug Mevacor.

“FDA approval of Mevacor is restricted to use under the supervision of a licensed health care professional,” the FDA advised in a July 9, 2021, announcement. “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.”

FDA laboratory analysis of Cholestene, which is marketed for cholesterol management, confirmed the presence of lovastatin, which is also used for high cholesterol.

On July 26, 2021, High Performance Formulas, LLC, initiated a recall for 14,848 bottles of Cholestene. Included in the August 25, 2021, FDA Enforcement Report, the recall affects 120-count bottles (UPC 640485-10093-4) from lot 30317 (Exp. 2/26). The capsules were manufactured by High Performance Formulas, Morrisville, PA, and distributed throughout the United States.

On August 15, 2021, the FDA designated the recall Class II, which further warns use of the product may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.