WARNING about Red Yeast Rice products

[Hannah]

From: MEDWATCH - The FDA Safety Information and Adverse Event Reporting Program [mailto:MEDWATCH@LIST.NIH.GOV] On Behalf Of CDER MEDWATCH LISTSERV
Sent: Thursday, August 09, 2007 4:10 PM
To: MEDWATCH@LIST.NIH.GOV
Subject: FDA - MedWatch - FDA Warns Consumers To Avoid Using Red Yeast Rice Products

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA warns consumers and healthcare professionals to avoid using 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 because the products may contain an unauthorized drug that could be harmful to their health. The products, promoted and sold over the internet as treatments for high cholesterol, contain lovastatin, the active pharmaceutical ingredient in Mevacor, a prescription drug approved for high cholesterol.

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. 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.

Read the complete MedWatch 2007 safety summary including a link to FDA News Release at:
http://www.fda.gov/medwatch/safety/2007 ... m#redyeast

[janb]

Yikes Hannah,

I just ran downstairs and pulled out my bottle of Poli-Chol Red. I take two pills a day to lower my cholesterol. It is made by a company called Natural Creations and my pharmacist recommended it. I only see 2 ingredients on the bottle:
Red Rice Yeast Extract 800 mg
Policosanol: 6 mg.
"Other ingredient" Rice Flour

I will discuss this with my pharmacist to ensure I'm safe with what I'm taking.
Thanks for the information
Jan

[Just Wondering]

Hannah,

I am not attempting to dispute your statement or the statement of the FDA, but something doesn't add up. If the problem lies in the assumption or fact that a statin is in the ingredient and the root of the problem, than all statin drugs are the problem, correct? My question becomes, what is the solution to lowering bad cholesterol? Aside from the obvious (diet and exercise)? Some people can eat all the right things and run 5 miles a day and still have highly dangerous LDL levels. I wish the FDA would make more recommendations and less warnings without solutions. The way I perceive it is, you're doomed either way.

Sincerely,

Seth

[PGLGreg]

The sin was marketing a product as a treatment for high cholesterol which contains a drug that is, actually, an effective treatment for high cholesterol. My mother has been taking lovastatin for a year or so, but that's okay, because hers was prescribed.

[Hannah]

I'm not making any statements - I don't know enough about the product to say much of anything, just reporting what the FDA has to say. I would be careful, as stated by the FDA. Products that contain unlisted drugs are dangerous because people don't know what they are taking, not necessarily because they are inherently dangerous.

For instance, I am allergic to several things - not a problem unless I take something that has one of those ingredients but doesn't list it! If products list their ingredients, we all know what we are taking. If they don't, I would steer clear. Also, there is a reason that prescription drugs are prescription and not over-the-counter. So that is another reason not to buy something over the counter that includes a prescription drug.

Hannah

[CRguy]

The issue that Hannah's post raises is not about a specific product so much as about product adulteration.

The entire problem with the so called health food and natural supplement industry is that there are not enough inspectors and inspections to ensure that what is on the label is what is in the bottle, AND more importantly that there is not something in the bottle which should not be there. Agencies just "trust" the maunfacturers and importers to a very large extent, to be legitimate. Many of these impure and altered products are coming from China where there is a huge problem with food and drug adulterations. (( the recent pet food scam with melamine added to increase the protein measurments and the contaminated heparin supplies just to name two )) In my practice, where I use acupuncture and herbals, I have chosen to avoid ANY product of origin in the People's Republic of China. I also avoid any products for home or personal use, and rely strictly on domestic suppliers and producers with a known record of integrity and safety.

Just my 2 cents and your mileage may vary considerably BUT you have been warned...buyer bewary, very wary.

Thanks for the heads up Hannah.

Cheers
CRguy

[jessica]

It's only being banned because it (the naturally-occurring statin) is a trademarked substance, and Merck would be losing money. True, it is a powerful substance, but there's no need for the FDA to go about banning it. They should just put warnings on the bottles, etc.

[CRguy]

No, the FDA should ban products which contain drugs which are not licensed to be in that product, or listed on the labels. Do you think Merck would mind if they could sell a lot more drug under proper license ??? I doubt it.

The issue is one of buying a bottle of "product A" and having good quality "product A" in the bottle and nothing else.
The issue is not one of having the consumer or FDA try to guess what is or isn't in that product, after the fact. If the producers or importers are putting out products which are not properly tested and/or inspected, then they should expect to lose their right to sell those products. It is all about protecting the consumer who has no way of determining if that product is safe or not.

Cheers
CRguy

[Jack Russell]

Unfortunately, your warning is greatly over exagerated.
The active ingredient(s) in red yeast rice are the family of monocolins (monocolin 1 thru 9 and monocolin-k). Monocolin-k is better known by its generic name of Lovastatin and its brand name, Mevacor. Lovastatin has been studied extensively (as have all statin drugs). The adverse effects you state can occur with any statin drug, and of which Lovastatin has no greater occurance than any other drug, and in particular Atorvastatin (Lipitor). This occurance is at a fraction of one percent. As for the other monocolins in RYR, it is proving that these work in synergy with their sibling monocolin-k to provide a greater cholesterol lowering effect at a lower dosage than just monocolin-k alone ( Lovastatin) with an even lesser load on the liver. I am living proff of red yeasts rice's benefits. My cholesterol was 250 (HDL 45). With RYR (5mg/daily) & niacin (in the form of inositol nicotinate at 2000mg/daily) I have lowered my total to 145 and increased my HDL to 60. I have effectively gone from the orange zone to the green zone.

[Hannah]

I must disagree here - first (and once again), this is not "my" warning - it's from the FDA, and second, the warning is not about whether a particular drug is safe or not. This warning was issued about a company who thinks it's okay to not list a prescription drug on its over-the-counter product label - ie, it's about a company not properly labeling their product, and selling prescription drugs as an over-the-counter remedy.

That is dangerous because without the warnings that come along with this prescription drug (and from the doctor and pharmacist who give it to someone), people can have some pretty bad side effects.

Even some things as seemingly-innocent as some mild painkillers (aspirin, ibuprofen, etc.) must be identified on a product label - because there are potential risks, especially for specific populations. For most of us, taking these wouldn't be a problem - but for my best friend who has Crohn's, she could land in the hospital from taking certain painkillers (because of the potential for major GI bleed), and my mom can only take certain ones because others can interact with her heart medication.

So that is what is happening here - if something is in a product, it should be listed and the appropriate warnings should be made. In this situation, they are not disclosing that this drug is in this product, which is why the FDA issued a warning.

Hannah

[PGLGreg]

... it's about a company not properly labeling their product, ...

Was a labeling law violated? What was improper about the labeling?

[CRguy]

From : <http://www.medscape.com/viewarticle/561289>
In the products that the FDA is currently targeting, lovastatin 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.

... it's about a company not properly labeling their product, ...

Was a labeling law violated? What was improper about the labeling?

You decide ! Would you want to buy a bottle of "aspirin" and find out it contained cortisone instead, but nobody bothered to mention that ??????????

A lot of people seem to be missing Hannah's point here so :

1. lovastatin, as a now generic drug, OR in a natural source preparation IS a potent active drug.
2. Potent active drugs are licensed for prescription use (lovastatin) because while they have potentially beneficial effects, they can also have very debilitating or lethal effects.
3. Trained professionals are in the best position to assess the risk/benefit of using one or more drugs in a given situation.
4. To know what you are dealing with you must have confidence in "what's in the bottle." AND...what's in the bottle must be accurately described on the label.
5. If people really don't care what's in the bottles of their medications or supplements, it is your choice and you might want to try some contaminated pet food or milk powder from China.


Cheers
CRguy

[PGLGreg]

I don't think that all chemical compounds present in natural products are required to be listed on labels. I have no opinion about whether the "lovostatin" should have been listed in this particular case, but I'm not willing to accept what appears to be a rather careless accusation that the labeling was improper without some evidence that this is actually true.

[Hannah]

Well, I'm pretty sure that the FDA doesn't much care what "our opinions" are about whether or not prescription drugs or controlled substances should be listed on labels or not. Like it or not, agree with it or not, it is the law and it's not subject to our opinions (or those of anyone at the FDA). If a company breaks these laws, the FDA is going to come breathing down its back (well, technically the FDA is only responsible for companies that participate in interstate commerce, so it will breathe down those companies backs!).

For me, I definitely agree with our laws that prescription drugs and controlled substances should have to be listed on labels, for all the reasons already said here (by me and others). But hey, it's okay if you don't agree with me about that - I hardly ever agree with the FDA 100%. But I am glad to live in a place where people it's illegal to put prescription drugs in something and lie about it to people buying it. So for me, I'm glad for our laws and for the regulatory controls the FDA has in place that have come into play in this situation.

The FDA studied these products, found that there was a substance in them that wasn't listed on the label, and because of the potential severity of that substance, they put out a public warning. It really doesn't have anything to do with which prescription drug they found, just that they found that these companies were including a drug that should have been listed and regulated, and they weren't doing that.

You don't have to agree with the law or believe the FDA that these companies were breaking it, but the companies doing business in this country do have to follow the law or they will face the consequences - in this case, the FDA will eventually shut them down if they don't stop selling these items illegally. Again, like it or not, this is the way it works.

PGLGreg, either you really don't understand or you are just being contrary - if you really don't understand, let me know and I'll walk you through this situation even more than has already been done here. If you don't trust the FDA's press release and would like to look at the information for yourself, you can contact the FDA at 888-INFO-FDA to request a copy of their information about this warning letter. If you are not satisfied with the information they have put together for the public on this topic, you can also make a Freedom of Information request for additional information (I would ask for the test results of the experiments they did on the products) at http://www.fda.gov/foi. If you just want to be contrary, knock yourself out - it's your time - but I won't be playing anymore!

Hannah

[PGLGreg]

Hannah, I did look up the warning letter sent to Swanson. It is here: http://www.fda.gov/foi/warning_letters/archive/s6455c.htm. In the letter, the FDA does allege that Swanson broke the law, but it does not allege that any labeling law was broken. The FDA's allegations concern including lovostatin in the product, not whether the label listed lovostatin. Your statements about some labeling law being violated seem, from what I have read so far, to be your own invention.

By the way, I do not see a reply to the FDA's warning letter in the FDA data base. And I looked up the Swanson web site, out of curiosity, and I see there, still for sale, several products with Red Yeast Rice and/or Polocosanol. But I can't tell whether these are the exact same products that the FDA warning was about.