Cholestene, a dietary supplement marketed for cholesterol management, has been found to contain a hidden drug ingredient, according to the Food and Drug Administration.

Based on laboratory analysis, the product, which is sold on various websites and in some retail stores, has been found to contain lovastatin, an HMG-CoA reductase inhibitor (statin). Consuming a supplement with an undeclared ingredient such as that in Cholestene may lead to serious adverse effects. The labeling on the product only indicates red yeast rice as the main ingredient.

Lovastatin, an FDA-approved prescription medication, is contraindicated in individuals with active liver disease or unexplained persistent elevations of serum transaminases, as well as in pregnant patients. It also should not be administered with strong CYP3A4 inhibitors as this may increase the risk of myopathy/rhabdomyolysis.

Adverse events related to the use of Cholestene should be reported to the FDA’s MedWatch program. Fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice may signal liver injury, while unexplained muscle pain, tenderness or weakness may be a sign of myopathy.


Continue Reading

Reference

Cholestene contains hidden drug ingredient. FDA.gov. Published July 8, 2021. Accessed July 12, 2021. https://www.fda.gov/drugs/medication-health-fraud/public-notification-cholestene-contains-hidden-drug-ingredient.