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Author Topic: Red Yeast Rice products/FDA Warning  (Read 949 times)
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JustMe
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« on: August 21, 2007, 10:23:04 AM »

I never looked at this warning when it came up on the FDA list. I didn't look until today as I never heard of it.  I had signed up for Consumer Lab emails.  Thanks to our members who have posted information from Consumer Labs.  I had never heard of them.

Anyway, this alert says some of these red yeast rice products contain an unauthorized drug, lovastatin.  Excuse me, what the heck is lovastin doing in these supplements?  Lovastatin is a cholesterol lowering drug (generic for Mevacor).  Release goes on to state that these products could lead to kidney impairment in some cases.

What is going on   Angry  I don't use this, just find it absurd.

http://consumerlab.com/recalls.asp#Recall_1
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« Reply #1 on: August 21, 2007, 12:03:30 PM »

Hard to say if it is a turf war or if there is really a prescription drug added to those products.  Did you notice that most of the rest of the products on that Consumer Lab warning list are diet or sexual performance aids?  Bunch of junk but the deep minds out there want that suff, I guess.



http://www.pccnaturalmarkets.com/health/Herb/Red_Yeast_Rice.htm
Historical or traditional use (may or may not be supported by scientific studies)
Since 800 A.D., red yeast rice has been employed by the Chinese as both a food and a medicinal agent. Its therapeutic benefits as both a promoter of blood circulation and a digestive stimulant were first noted in the traditional Chinese pharmacopoeia, Ben Cao Gang Mu-Dan Shi Bu Yi, during the Ming Dynasty (1368–1644).2 Practitioners of Traditional Chinese Medicine use red yeast rice to treat abdominal pain due to stagnant blood and dysentery, as well as external and internal trauma.3 In addition to its therapeutic applications, red yeast rice has been used for centuries as a flavor enhancer, a food preservative, and a base for a Taiwanese alcoholic rice-wine beverage.4 5

Active constituents
In addition to rice starch, protein, fiber, sterols, and fatty acids, red yeast rice contains numerous active constituents, including monacolin K, dihydromonacolin, and monacolin I to VI.

Researchers have determined that one of the ingredients in red yeast rice, called monacolin K, inhibits the production of cholesterol by stopping the action of a key enzyme in the liver (e.g., HMG-CoA reductase) that is responsible for manufacturing cholesterol.6 The drug lovastatin (Mevacor®) acts in a similar fashion to this red yeast rice ingredient. However, the amount per volume of monacolin K in red yeast rice is small (0.2% per 5 mg) when compared to the 20–40 mg of lovastatin available as a prescription drug.7 This has prompted researchers to suggest that red yeast rice may have other ingredients, such as sterols, that might also contribute to lowering cholesterol.

Along with its evaluation in animal trials,8 red yeast rice has been clinically investigated as a therapy for reducing cholesterol in two human trials. In one trial, both men and women taking 1.2 grams (approximately 13.5 mg total monacolins) of a concentrated red yeast rice extract per day for two months had significant decreases in serum cholesterol levels.9 In addition, people taking red yeast rice had a significant increase in HDL (“good”) cholesterol and a decrease in LDL (“bad”) cholesterol. Elevated triglycerides were also found to be lowered.

A double-blind trial at the UCLA School of Medicine determined that red yeast rice in the amount of 2.4 grams per day (approximately 10 mg total monacolins) in capsules significantly decreased total- and LDL-cholesterol levels in a sample of people with elevated cholesterol after 12 weeks of therapy. Triglycerides were also reduced in those taking red yeast rice. However, unlike the original study, HDL values did not increase substantially.10

How much is usually taken?
The red yeast rice used in various studies was a proprietary product called Cholestin®, which contains ten different monacolins. The amount of Cholestin used in these studies was 1.2–2.4 grams (5–10 mg of monacolins) per day in divided amounts for 8-12 weeks.11 12

Note: Cholestin has been banned in the United States, as a result of a lawsuit alleging patent infringement.

Other red yeast rice products currently on the market differ from Cholestin in their chemical makeup. None contain the full complement of ten monacolin compounds that are present in Cholestin, and some contain a potentially toxic fermentation product called citrinin.13 Despite these concerns, other red yeast rice products are being widely used and anecdotal reports suggest that they have a similar safety and efficacy profile as that of Cholestin.

Are there any side effects or interactions?
The Cholestin brand of red yeast rice has been generally well tolerated with possible temporary mild side effects such as heartburn, gas, and dizziness.14 This product should not be used by people with liver disorders15 and its safety during pregnancy has not been established. As in the case of medications that inhibit HMG-CoA, it is advisable that people using red yeast rice products also supplement 30–60 mg of coenzyme Q10 daily.

There is one case report of muscle weakness and joint pain occurring in a man who was taking red yeast rice.16 Because the man was also taking several prescription drugs, it was not clear whether the symptoms were caused by red yeast rice. The report should be taken seriously, however, since muscle problems are common side effects of prescription HMG CoA-reductase inhibitors.

Are there any drug interactions?
Certain medicines may interact with red yeast rice. Refer to drug interactions for a list of those medicines.

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JustMe
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« Reply #2 on: August 21, 2007, 01:01:50 PM »

Maybe the drug companies just don't want any cheaper competition.
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« Reply #3 on: August 21, 2007, 01:20:57 PM »

I understand this is a supplement right?  Not yet in prepackaged foods?  Good God..
 
Here is a warning: From Nature's Sunshine, Red Yeast Rice... http://www.greatestherbsonearth.com/nsp/red_yeast_rice.htm
 
Important: Do not take this product if: Pregnant, lactating, or planning pregnancy. Consult your health care provider before using if you are currently taking any cholesterol-lowering agents. Cholesterol levels should be checked regularly. For adults 20 years of age or older. Keep out of the reach of children. Red Yeast Rice is for adults only. People with, or at risk for, liver disease should not use this product.

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Laurie
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« Reply #4 on: August 21, 2007, 01:48:21 PM »

    My friend has been suggesting to me for years to take the red rice for high cholesterol. Red rice yeast naturally produces lovastatin when fermented. In 1999 the FDA went after the companies who were selling it. The court of appeals ruled that it was to be regulated by the FDA. So the majority of red rice yeast that is now sold as a supplement does not have the lovastatin in it as many are now using a different form of fermentation. So now it has lost it's effectiveness as an aid in reducing cholesterol. Although there are a few brands yet available that still contain the lovastatin. I would definitely say the pharmaceutical companies had a hand in this and that they did not want the competition.          http://heartdisease.about.com/cs/cholesterol/a/Nrxcol_rry.htmhttp://heartdisease.about.com/b/a/254767.htm
« Last Edit: August 21, 2007, 01:55:23 PM by Laurie » Logged
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« Reply #5 on: August 21, 2007, 04:09:14 PM »

Thank you Laurie for clarifying that..

I do hope they don't go so far as to embed it within foods unawares.. especially since there are warnings and it has been stripped of it's true medicinal values as a suppliment that once was.
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KimS
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« Reply #6 on: August 22, 2007, 11:58:41 AM »

Ok, this reminds me of something.
I used to take supplements for everything. Gingko, Ginsing, Valarian Root etc etc....
If it was said to make me feel better I took it. Vitamins included.
Well I didn't feel better. I felt weird.

I may have had some psychological benefit but basically I was just taking a bunch of UNKNOWN and unregulated
herbs with no real knowledge on how they would interact with each other.
And I was in my own way self medicating.

I turned orangish. Gelatin tablets would burst if I burped and weird powder would fly out of my mouth. Gross!
So I stopped and I feel better than I ever have.
No vitamins, no herbs. Just healthy food and water.

I eat unhealthy sometimes (Yum Yum)  but I pass the overpriced herbal supplements and vitamins section when I'm at Whole Foods now.

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Poco
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« Reply #7 on: August 22, 2007, 03:54:23 PM »

"I burped and weird powder would fly out of my mouth. "

 Grin  I still take some supplements that I think have value, but I did cut way back after all the recent revelations.  That has not happened to me since then.  I think moderation and prudence are the key here.  I guess I was not the only one going hog-wild with that stuff.  It has been a sanity check, that is for sure.  Grin
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KimS
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« Reply #8 on: August 22, 2007, 04:12:48 PM »

I have a hard time being moderate. That's my big project for the next 50 years of my life.
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Miu
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« Reply #9 on: August 23, 2007, 03:51:53 AM »

Red yeast rice is a natural alternative to expensive statin drugs used for lowering cholesterol. Is it any surpise that it contains lovastatin?
It is most likely a naturally occuring chemical in red yeast rice. Someone in my family is using it instead of a prescription statin drug. It
lowered his cholesterol from 180 to 140, and is maintaining it at that level.
« Last Edit: August 23, 2007, 05:05:39 AM by Miu » Logged
JustMe
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« Reply #10 on: August 23, 2007, 04:13:48 AM »

Very interesting, Miu.  That is good news for your family member.  No adverse reactions to it?

I'm still wondering if it is a $$$ issue in that the drug manufacturers don't want competition.  Like how they don't want us buying prescription medications from Canada.  With all we've learned lately, I don't have much confidence in prescription medications here containing only what they are supposed to contain.  I lot of the brand name and generics get recalled, too.
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« Reply #11 on: August 23, 2007, 09:47:10 PM »

Why is everyone so possessed with lowering their cholesterol? Your body needs this to survive including your brain. Not the kind you get from the greasy, fried foods with all the trans fat but the good cholesterol. Look up cholesterol: lowering it too much can be dangerous and might even kill you. Remember dead doctors don't lie.
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KimS
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« Reply #12 on: August 24, 2007, 12:17:03 AM »

There's good cholesterol and bad. And a lot of the time it is hereditary. There's also good fat and bad fat, good carbs and bad, good and evil, Laurel and Hardy, and Tom and Jerry.
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Miu
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« Reply #13 on: August 24, 2007, 04:34:49 AM »

Very interesting, Miu.  That is good news for your family member.  No adverse reactions to it?

I'm still wondering if it is a $$$ issue in that the drug manufacturers don't want competition.  Like how they don't want us buying prescription medications from Canada.  With all we've learned lately, I don't have much confidence in prescription medications here containing only what they are supposed to contain.  I lot of the brand name and generics get recalled, too.

I asked my red yeast rice user for some answers. Lovastatin occurs naturally in red yeast rice... just as vitamin C occurs naturally in
oranges. He's been using it for several years instead of an expensive statin drug his doctor prescribed. It works and has no adverse
side effects. He gets a blood test and physical annually and the doctor knows he's using a natural alternative.

I think we can conclude that the warning from FDA involves a conspiracy with greedy big pharma!!
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KimS
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« Reply #14 on: August 24, 2007, 03:43:22 PM »

FDA are pretty corrupt, I wouldn't put it past them.
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