Cholesterol-lowering red yeast rice products vary

NEW YORK (Reuters Health) - Red yeast rice products, marketed as a natural alternative to drugs that lower cholesterol, vary widely in the amount of active ingredients they contain, and some may be contaminated, new research shows.

The study, published this week in the Archives of Internal Medicine, draws on data from past studies to show that 12 different supplements had varying levels of monacolin K -- the chemical in red yeast rice that is believed to lower cholesterol.

The products ranged from 0.2 milligrams of monacolin K to 14.5 milligrams per daily dose, a difference the authors call "striking."

"All of the bottles we looked at looked good. They looked professional and said they contained the same amount of red yeast rice, but they still varied in active ingredients," Dr. Ram Gordon, who worked on the study, told Reuters Health.

The researchers also found that four of the products were contaminated with citrinin, a toxin that hasn't been tested in humans but can cause kidney damage in some animals.

According to the Nutrition Business Journal, Americans spent $20 million on red yeast rice products in 2008. Studies have shown they can improve cholesterol levels when combined with lifestyle changes, making them a potential alternative to cholesterol drugs for patients who experience side effect such as muscle and joint pain (see Reuters Health story of June 15, 2009).

The cholesterol drug Mevacor and its generic forms contain the same active ingredient -- monacolin K -- as red yeast rice supplements, but to make the drugs, companies process it into its purified form, called lovastatin.

On average, the products in the study contained 6 milligrams of lovastatin per daily dose, which Gordon, a cardiologist at Chestnut Hill Hospital in Flourtown, PA, said is a fraction of what patients get from the typically prescribed dose of cholesterol drugs.

However, for five of the red yeast rice products, the recommended daily dose was at or above 10 milligrams of lovastatin, which is the lowest recommended daily dose of Mevacor.

Lovastatin levels this high, explained Gordon, could have the same side effects that many patients taking the supplements are hoping to avoid.

In 2007, the U.S. Food and Drug Administration issued a statement to consumers, warning them of these risks and telling them to stay away from three different brands of red yeast rice supplements because they contained higher levels of lovastatin.

The FDA also told companies that red yeast rice products must contain only trace amounts of the chemical, though they did not provide a specific limit.

Max Willis, vice president of marketing at Solaray, whose Red Yeast Rice product was used in the study, explained that lovastatin levels can vary naturally depending on the batch of red yeast and rice ingredients used to make the supplement.

"Supplements are basically an extension of foods. Foods grow from the ground, so their chemicals can naturally occur at different levels," explained Willis. "With red yeast rice, the lovastatin may vary batch to batch."

The authors of the paper call for more regulations to limit these inconsistencies and ensure product safety, but Willis wasn't sure that further FDA action is necessary.

Instead, he said it's up to individual companies to test their products and ensure they comply with the rules that are already laid out, including the Dietary Supplement Health and Education act of 1994 and the FDA's Good Manufacturing Practices guidelines.

Gordon's concern, however, is that product labels do not contain enough information for the people interested in buying them.

"It's difficult for doctors and consumers to determine what's good and what's bad," Gordon said. "You don't necessarily know what you're getting when you walk into, say, a GNC and pick up one of these products."

SOURCE: link.reuters.com/kaf42q Archives of Internal Medicine, October 25, 2010.