OT:FDA warns doctors, consumers about red yeast supplements found to contain l

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FDA warns doctors, consumers about " red yeast " supplements found to

contain lovastatin

TheHeart.Org - New York,NY*

August 10, 2007 Wood

http://www.theheart.org/article/805737.do

Rockville, MD - The FDA is warning physicians and consumers to steer

clear of several " cholesterol-lowering " supplements that may

illegally contain lovastatin [1].

FDA testing revealed that several brands of nonprescription " red

yeast extract " supplements, marketed as Red Yeast Rice, Red Yeast

Rice/Policosonal Complex, and Cholestrix, contained lovastatin, a

prescription drug. Not surprisingly, the agent is not named in the

list of product ingredients. The products are manufactured by

Nature's Value Inc, Kabco Inc, and Sunburst Biorganics,

respectively, and sold over the internet by the manufacturers, or in

the case of Red Yeast Rice, by Swanson Healthcare Products.

The FDA's Medwatch issued an alert about the products earlier this

week, noting that 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, " an FDA press release states. " 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. "

Under the US Dietary Supplement Health and Education Act of 1994,

the manufacturer of a supplement is responsible for ensuring that

its product is safe prior to going on the market, but it does not

need to register their product with the FDA or get FDA approval. The

FDA can take action postmarketing against any unsafe dietary

supplement after it reaches the market.

Source

FDA. 2007 safety alerts for drugs, biologics, medical devices, and

dietary supplements: Red Yeast Rice, Red Yeast Rice/Policosonal

Complex, Cholestrix. August 9, 2007. Available at:

http://www.fda.gov/medwatch/safety/2007/safety07.htm#redyeast.