US consumers warned to avoid red yeast rice products promoted as treatments for high cholesterol

The US Food and Drug Administration (FDA) has warned consumers not to use three red yeast rice products promoted and sold on websites. The products may contain an unauthorised drug that could be harmful to health. The products are promoted as dietary supplements for treating 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 USA as a treatment for high cholesterol. There is the possibility that 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 anti-depressant nefazodone, certain antibiotics, drugs used to treat fungal infections and HIV infections, and other cholesterol-lowering medications.

<http://www.fda.gov/bbs/topics/NEWS/2007/NEW01678.html>, accessed September 24, 2007.