FDA - MedWatch - FDA Warns Consumers To Avoid Using Red Yeast Rice Products

[Guest guest]

FYI

 

Nameste, Mary

 

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CDER MEDWATCH LISTSERV <MEDWATCHLIST

Aug 9, 2007 4:09 PM

FDA - MedWatch - FDA Warns Consumers To Avoid Using Red Yeast

Rice Products

MEDWATCH

 

 

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.

 

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