August 10, 2007 [ corrected and updated August 14] (Rockville, MD) - The FDA is warning physicians and consumers to steer clear of several cholesterol-lowering supplements that contain what the FDA terms "unauthorized" lovastatin [ 1].
FDA testing revealed that several brands of nonprescription "red yeast rice extract" supplements, marketed as Red Yeast Rice, Red Yeast Rice/Policosonal Complex, and Cholestrix, contained lovastatin, a regulated prescription drug. In a MedWatch safety alert, the FDA tells consumers to "avoid using" the products because they "may contain an unauthorized drug that could be harmful to their health." Not mentioned in the FDA alert is the fact that lovastatin, marketed as Mevacor, first isolated from a fungus, also occurs naturally in certain forms of red yeast rice that are made when rice is cultivated with the mold Monascus purpureus. Red yeast rice has been used in traditional Chinese medicine for centuries to promote blood circulation and digestion. In 1998 the FDA banned the sale of a red yeast supplement, Cholestin, because it contained lovastatin; the supplement was later permitted to be sold, but without red yeast rice.
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.
The FDA's Medwatch alert notes that 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," an FDA press release states. "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."
Under the US Dietary Supplement Health and Education Act of 1994, the manufacturer of a supplement is responsible for ensuring that its product is safe prior to going on the market, but it does not need to register its product with the FDA, get FDA approval, submit its product to preapproval testing, or even prove that the product contains the ingredients listed. The FDA can take action postmarketing against any unsafe dietary supplement after it reaches the market.
FDA. 2007 safety alerts for drugs, biologics, medical devices, and dietary supplements: Red Yeast Rice, Red Yeast Rice/Policosonal Complex, Cholestrix. August 9, 2007. Available at: https://www.fda.gov/medwatch/safety/2007/safety07.htm#redyeast .
An earlier version of this story, which suggested lovastatin had been "illegally" added to the supplements, provoked a flurry of emails, urging a closer look at the history of the product and the FDA's handling of naturally occurring lovastatin. Most of the physicians who contacted heartwire pointed out that it was a legitimate move on the part of the FDA to alert physicians to the possibility that lovastatin dosages may be boosted if patients are taking red yeast rice on top of a statin and to the possibility that patients taking the supplement may experience the known side effects of statin drugs. But most also pointed out that the dose of lovastatin in red yeast rice is likely to be significantly lower than that of prescription lovastatin, now a generic drug in the US.
Medscape Medical News © 2007 Medscape
Cite this: Shelley Wood. FDA Warns Doctors, Consumers About Red Yeast Supplements Found to Contain Lovastatin - Medscape - Aug 10, 2007.