FDA Warning: Red Yeast Rice Products

Filed in archive News , Treatment on August 10, 2007

Consumers should not buy or eat three red yeast rice products that are sold on web sites and promoted as dietary supplements for high cholesterol treatment.

The US FDA warns that these products may contain an unauthorized drug that could be harmful to health.

[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.]

As revealed by FDA testing, these products contain lovastatin - the active ingredient in Mevacor (a pdf file) - a prescription drug approved for marketing in the United States as a treatment for high cholesterol.

According to Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research:

"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."

Lovastatin can cause severe muscle problems leading to kidney impairment.

Source: FDA News

I guess that FDA just wanted to sort of screen these products because they didn't go through their normal approval process.

Would you buy not-FDA approved products such as Red Yeast Rice?

[In Photo: Nature's Plus - Red Yeast Rice Extended Released, 600 mg, 30 tablets at Amazon]