Cholesterol :: Avoid red yeast rice ---says FDA

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    Cholesterol :: Avoid red yeast rice ---says FDA


    Avoid red yeast rice products promoted on internet as treatments for high cholesterol, says FDA

    I am using Red Yeast Rice from NowFoods.
    Probably same thing.
    Am I in some kind of trouble?
    My cholesterol went from about 230 to 154 within 6 months, using 2 600mg pills. Since that blood tes, I cut down to 1pill/day.
    I use CoQ10 and othe supplements.
    ============================== ===============
    Cholesterol :: Avoid red yeast rice products promoted on internet as treatments for high cholesterol, says FDA
    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: Most Recent Warning Letters.

    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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    Lovastatin has always been the active ingredient labeled in the red yeast rice products I have seen. I'm not sure what their problem is with it now unless some of the products are adding additional lovastatin to the natural occurring form in the product.
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    I will post this up or post a link to it in the anabolic innovations forum
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    Quote Originally Posted by RPHMark View Post
    Lovastatin has always been the active ingredient labeled in the red yeast rice products I have seen. I'm not sure what their problem is with it now unless some of the products are adding additional lovastatin to the natural occurring form in the product.
    The FDA is going to bat for big pharma... again

    Red Yeast Rice
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    Yeah..don't take it because when a supp company sells it..it's horribly dangerous. But when a pharmacuetical company sells it..it's the best thing since sliced bread and FDA approved with a smile
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    Quote Originally Posted by RPHMark View Post
    Lovastatin has always been the active ingredient labeled in the red yeast rice products I have seen. I'm not sure what their problem is with it now unless some of the products are adding additional lovastatin to the natural occurring form in the product.
    Sounds to me like someone is pissed that a supp company is digging into their profits.
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    Fox News had a spot today (8-26) in which the doctor claimed the FDA had won an appeal to remove the active ingredient in RYR supplements. Does anyone know if there is any truth to this? He said there were a few companies who did not comply (some of the above). NOW wasn't listed as one. He said all the others were basically useless, since the active ingredient was now removed.
  

  
 

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