FDA warns against Internet red yeast products

Promoted as dietary supplement treatments for consumers with high-cholesterol, red yeast rice and red yeast rice/policosonal complex, sold by Swanson Healthcare Products, and manufactured by Nature's Value and Kabco respectively; and Cholestrix, sold by Sunburst Biorganics, are all thought to contain Lovastin. Swanson and Sunburst Biorganics have been ordered by the US Food & Drug Administration (FDA) in warning letters to stop selling and promoting the red yeast products - with the threat of risk enforcement actions, such as an injunction against continuing violations and a seizure of products if the companies do not resolve the violations. The letters state that the products red yeast rice, red yeast rice/policosonal complex, and Cholestrix sold on the firm's websites are in violation of the Federal Food, Drug and Cosmetics Act and are being sold without approval. Lovastin is an active pharmaceutical ingredient in Mevacor, a prescription drug approved in the treatment for high cholesterol, thought to cause severe muscle problems leading to kidney impairment when taken in un-prescribed, large quantities. "This risk is even more serious because consumers may not know the side effects associated with lovastatin and the fact that it can adversely interact with other medications,"​ said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. Indeed, the risk is said to be intensified in patients who take higher doses or who combine does of lovastatin combined with other medication that heightens adverse muscle reactions. A wide range of drugs come under this category, including the antidepressant nefazodone, certain antibiotics, drugs used to treat fungal infections and HIV infections, and other cholesterol-lowering medications. The FDA has advised consumers who have used rice yeast products and have had adverse reactions to consult their health care provider, whilst reporting reactions to MedWatch, the FDA's voluntary reporting program. The warning letters are available for review on the FDA website.