FDA warns consumers to avoid two supplements that contain unauthorized drugsThe FDA has recently warned consumers about buying and using supplements that were found to contain unauthorized drugs. These products are:
- Red Yeast Rice and Red Yeast Rice/Policosanol Complex, sold by Swanson Healthcare Products and manufactured by Nature's Value and Kabco, respectively; and Cholestrex, sold by Sunburst BiOrganics. These products were found to contain lovastatin, the active pharmaceutical ingredient in Mevacor®, a prescription drug approved for marketing in the United States as a treatment for high cholesterol. The red yeast products have been promoted as dietary supplements for treating high cholesterol.
These red yeast rice products can threaten health because lovastatin can cause severe muscle problems leading to kidney impairment, the FDA says. 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.
The FDA has issued warning letters advising Swanson and Sunburst BiOrganics to stop promoting and selling the products. The FDA warning letters state that the products Red Yeast Rice, Red Yeast Rice/Policosanol Complex, and Cholestrex, sold on the firm's web sites, 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. The 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.
- METABOSLIM Apple Cider Vinegar brand dietary supplement. Confidence of Port Washington, NY, has issued a voluntary nationwide recall in the United States and Canada of one lot of the supplement, which was found to contain sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss.
The recalled lot has the number 3001006, EXP. 102009 and UPC CODE: 92483 00102. This lot was primarily sold in Canada. The product is sold in a plastic bottle with white and red labeling and contains 60 gelatin capsules.
Confidence has been informed by the FDA that lab analysis of METABOSLIM samples found that the product contains undeclared sibutramine The FDA has not approved METABOSLIM as a drug; therefore, the safety and effectiveness of this product is unknown.
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. No illnesses or injuries have been reported to the company to date in connection with this product.