Re:Fw: FDA Warns Consumers to Avoid Red Yeast Rice Products Promoted on

August 11, 2007

I can't speak from experiance here but joined 2 statin

groups and from what they say, the red yeast rice is just as effective as statin

drugs but even at worst have far less side effects. Many people that have

tried both the drugs as well as the rice say that they didn't get any side

effects at all with the rice - few whom didn't try the rice until after they

were

injured by the drugs do sometimes get similar side effects from the rice. But

still the side effects are not as severe as with the drugs. Too bad they don't

take the drugs off of the market.

blessings

Shan

Fw: FDA Warns Consumers to Avoid Red Yeast Rice Products Promoted on

Posted by: " Michelle Ives " mmives shellyct

Fri Aug 10, 2007 12:27 pm (PST)

FDA Press Release

This listserv covers mainly Class I (life-threatening) recalls. A complete

listing of recalls can be found in the FDA Enforcement Report at:

http://www.fda.gov/opacom/Enforce.html

FOR IMMEDIATE RELEASE

August 9, 2007

Media Inquiries:

Catherine McDermott, 301-827-6242

Consumer Inquiries:

888-INFO-FDA

FDA Warns Consumers to Avoid Red Yeast Rice Products Promoted on Internet as

Treatments for High Cholesterol

Products found to contain unauthorized drug

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:

www.accessdata.fda.gov/scripts/wlcfm/recentfiles.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.

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.

####

FDA's Recalls, Market Withdrawals and Safety Alerts Page:

http://www.fda.gov/opacom/7alerts.html

August 12, 2007

The FDA is proving once again that they are agents of the big

Pharms.The FDA tried to have red rice yeast banned but the courts rule that they

could not do it because it was giving undue favor to to the pharms. and that

they would have to show due cause for banning RRY.They had to prove a risk to

the public. They could not do it without exposing statin drugs.

Once again they trying to ban RRY for the favor of statin drugs. Yes

it should be common sense not to use statin drugs and RRY at the same time.But

since common sense is uncommon perhaps both the statin drugs and RRY labels

should give this warning.

Pryor to the pharms telling us that our cholesterol is too high ,208

to 245 was normal . Also the ratio between HDL and LDL is 1:6 or less

Cholesterol is not a big factor. The only thing that has change is the profits

for the BIG PHARMS.

surpriseshan2 wrote: