FDA Warns Consumers to Avoid Red Yeast Rice Products

The U.S. Food and Drug Administration (FDA) has issued a safety alert warning consumers not to buy or consume three different types of red yeast rice products sold and promoted online. The products may contain an unauthorized drug that can be harmful. The product is promoted as a dietary supplement used to aide high cholesterol.

The potentially harmful products are: Red Yeast Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, Inc. and manufactured by Nature’s Value Inc. and Kabco Inc., respectively; and Cholestrix, sold by Sunburst Biorganics. FDA testing revealed the products contain lovastatin, the active pharmaceutical ingredient in Mevacor, a prescription drug approved for marketing in the United States as a treatment for high cholesterol.

“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.

The products are dangerous to health because they may contain lovastatin which can cause severe muscle problems that may lead to kidney damage. The risk is increased in patients who take larger dosages of lovastatin or who combine lovastatin and other medicinces also know to increase the risk of muscle reactions. Such drugs include the antidpressant nefazodone, certain antibiotics, drugs used for fungal infections and other cholesterol-lowering medications.

The FDA has issued warning letters to Swanson and Sunburst Biorganics to stop promoting and selling the recalled products.