Medwatch Warning-Red Yeast Rice

saluki

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

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.

Read the complete MedWatch 2007 safety summary including a link to FDA
News Release at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#redyeast.