FDA Warns Doctors, Consumers About "Red Yeast" Supplements Found to Contain Lovastatin
Shelley Wood

August 10, 2007 (Rockville, MD) - The FDA is warning physicians and consumers to steer clear of several "cholesterol-lowering" supplements that may illegally contain lovastatin .
FDA testing revealed that several brands of nonprescription "red yeast extract" supplements, marketed as Red Yeast Rice, Red Yeast Rice/Policosonal Complex, and Cholestrix, contained lovastatin, a prescription drug. Not surprisingly, the agent 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 issued an alert about the products earlier this week, noting 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 their product with the FDA or get FDA approval. 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: http://www.fda.gov/medwatch/safety/2007/safety07.htm#redyeast.