Red Yeast Rice, Lovastatin Warning

WASHINGTON—FDA (www.FDA.gov) is warning consumers not to buy or eat three red yeast rice products promoted and sold on Web sites, as they may contain an unauthorized drug that could be harmful to their health. The products—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—are promoted as dietary supplements for treating high cholesterol, but FDA said tests 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. FDA advises consumers who use any red yeast rice product to consult their health care provider if they experience problems that may be due to the product.

“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., director of FDA’s Center for Drug Evaluation and Research.

FDA warned these red yeast rice products are a threat to health due to the possibility lovastatin can cause severe muscle problems leading to kidney impairment. This risk is greater in patients who take higher doses of lovastatin or who take lovastatin and other medicines that increase the risk of muscle adverse reactions. These medicines include the antidepressant nefazodone, certain antibiotics, drugs used to treat fungal infections and HIV infections, and other cholesterol-lowering medications.

FDA has issued warning letters advising Swanson and Sunburst Biorganics the offending products are unapproved new drugs marketed in violation of the Federal Food, Drug, and Cosmetic Act; The companies were ordered to stop promoting and selling the products or face possible enforcement actions, such as an injunction against continuing violations and a seizure of illegal products.