Fw: FDA Warns Consumers to Avoid Red Yeast Rice Products Promoted on Internet as Treatments for High Cholesterol

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FDA Press Release

 

 

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FOR IMMEDIATE RELEASE

August 9, 2007

Media Inquiries:

Catherine McDermott, 301-827-6242

Consumer Inquiries:

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FDA Warns Consumers to Avoid Red Yeast Rice Products Promoted on Internet as

Treatments for High Cholesterol

Products found to contain unauthorized drug

The U.S. Food and Drug Administration is warning consumers not to buy or eat

three red yeast rice products promoted and sold on Web sites. The products may

contain an unauthorized 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 United States as a treatment for

high cholesterol.

 

" 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., M.P.H., director of FDA's Center

for Drug Evaluation and Research.

 

These red yeast rice products are a threat to health because the possibility

exists 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 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 to stop

promoting and selling the products. Companies that do not resolve violations in

FDA warning letters risk enforcement actions, such as an injunction against

continuing violations and a seizure of illegal products.

 

The FDA warning letters state that the products Red Yeast Rice, Red Yeast

Rice/Policosonal Complex, and Cholestrix, sold on the firm's websites, are

unapproved new drugs that are marketed in violation of the Federal Food, Drug,

and Cosmetic Act. The warning letters are available on FDA's Web site:

www.accessdata.fda.gov/scripts/wlcfm/recentfiles.cfm.

 

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.

 

Report adverse events related to these products to MedWatch, the FDA's voluntary

reporting program:

www.fda.gov/medwatch/report.htm; 800-332-1088; Fax: 800-332-0178; and MedWatch,

Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.

 

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