Red yeast rice supplements, sold as a “natural” alternative to cholesterol-lowering statin drugs, vary widely in how much active ingredient they contain and some are contaminated, U.S. researchers reported on Monday.

Americans thinking they are getting a reliable and safe alternative to prescription drugs should take a closer look, and regulators should consider stricter limits on the products, Dr. Ram Gordon of Chestnut Hill Hospital and the University of Pennsylvania and colleagues said.

They tested 12 commercially available products and found great variation in how much active ingredient each actually contained.

“One-third of the products tested were contaminated with citrinin,” they wrote in the Archives of Internal Medicine. Citrinin is a so-called mycotoxin that can alter DNA, which means it could potentially cause cancer.

Red yeast rice contains 14 active compounds called monacolins that slow the liver’s production of cholesterol.

Each of the 12 products tested was labeled “600 mg/capsule” of active product.

“Although statins and other proven prescription lipid-lowering therapies have been available for decades, many patients seek alternative therapies to lower their cholesterol levels,” the researchers wrote.

The first statin, lovastatin, was in fact based on red yeast rice.

In 1998, the U.S. Food and Drug Administration ruled that a product called Cholestin was not a dietary supplement but an unapproved drug - in essence, a source of lovastatin. Maker Pharmanex, now a subsidiary of Nuskin, removed red yeast rice from Cholestin.

$20 MILLION MARKET

But consumers may be getting statins from the supplements anyway.

“In 2008, American consumers spent $20 million on this dietary supplement, an 80 percent increase compared with 2005,” the researchers wrote, citing the Nutrition Business Journal.

“However, to avoid being considered an unapproved drug by the FDA, red yeast rice manufacturers typically do not disclose levels of lovastatin or other monacolins in their products, and there is no standardization of these levels across manufacturers.”

Some of the products they tested included 21st Century 100 percent Vegetarian Red Yeast Rice Extract from 21st Century Healthcare in Tempe, Arizona, and Schiff New Red Yeast Rice from Schiff Nutrition Group in Salt Lake City, Utah.

The researchers did not say which products had the highest or lowest levels of active ingredients and which were contaminated.

The health implications are clear, they said.

“Most Americans perceive naturally derived products as safe and as effective as regulated pharmaceuticals and about 60 percent of patients do not reveal the use of dietary supplements or alternative medications to their health care providers,” they wrote.

They said anyone taking the supplements should tell their doctors, as statins can have serious side-effects including muscle breakdown.

The $20 million market for the supplements is a small dent in the overall market for statins, the world’s best-selling drugs. Consumer Reports estimates the U.S. market for statins to be $14 billion. (Editing by Jim Marshall)

SOURCE:  Archives of Internal Medicine, October 25, 2010.