FDA issues warning to Red Yeast Rice Users!

[dinoiii]

If you have been reading my material over the years, this obviously comes as NO surprise. I have offered a note of warning that ALL products containing this agent are completely "NONsensical" and illegal if they contain what they usually promote (but usually don't contain the illegal component anyway and are essentially pointless)...transmission to follow:




FDA Warning on Red Yeast Rice Products
(Date Posted: 8/9/2007)
On August 9, 2007, the U.S. Food and Drug Administration (FDA) warned 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: http://www.accessdata.fda.gov/script...ecentfiles.cfm.

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.



D_

[B-natural]

Is this your way of saying I told you so....yet again... lol

[dinoiii]

Originally Posted by B-natural

Is this your way of saying I told you so....yet again... lol

Not really at all actually!

BUT I have literally stood on my head with this one to get the point across and some people remain insistent on using this product which disturbs me. That said, the PCT time frame, when this product typically earns use...people will still attempt to call my bluff and tell me it is terrible advice I am giving. I will continue to preach negative sentiment on this one and as I have said, killing off androgenic substrate during PCT is an absolute farse and people suggesting the contrary have NO IDEA what they are talking about and you should step FAR AWAY from their advice.

So, what about people that boast "phenomenol" cholesterol values D? Well I'll tell you why this is asinine - cholesterol malfunctioning will return to normal AS THE BODY SEES FIT (when androgenic substrates pull everything together and endogenous makeup is not further warranted) AS PCT PROGRESSES. There is a significant confounding variable and they call the ooohs and ahhhs of the masses when their values may have gotten better after 4-6 weeks of a PCT...I say horsesh*t!



D_

[B-natural]

lol, sooooo angry.....

I remember starting my first cycle, and the research, and there was a general recommendation of what to use for pct. So, I did a little research on it, as I do not just say f*** it and use what I'm told. This one had up and down reports. I did suffer through it, as I found positives and negatives, then I read your pct articles (I found them afterwards) and realized it wasn't the best product to be taking. Oh and the headaches that everyone is supposed to live through, those SUCKED!