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Red Yeast Rice/Policosonal Complex

August 9, 2007

Audience: Consumers and healthcare professionals

[Posted August 09, 2007] FDA warns consumers and healthcare professionals to avoid using 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 because the products may contain an unauthorized drug that could be harmful to their health. The products, promoted and sold over the internet as treatments for high cholesterol, contain lovastatin, the active pharmaceutical ingredient in Mevacor, a prescription drug approved for high cholesterol.

Lovastatin can cause severe muscle problems leading to kidney impairment. The 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 such as nefazodone (an antidepressant), certain antibiotics, drugs used to treat fungal infections and HIV infections, and other cholesterol lowering agents. Consumers who use any red yeast rice products should consult their healthcare provider if they experience any problems that may be due to these products.

[August 09, 2007 - News Release - FDA]

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