Recalls

Doctor’s Best Red Yeast Rice pills contain undeclared statin medication

Recall Red Yeast Rice1 Doctors Best Red Yeast Rice pills contain undeclared statin medicationDoctor’s Best is recalling more than 7,000 bottles of its Red Yeast Rice dietary supplement, used to “naturally” lower cholesterol levels, because the product was found to contain lovastatin, the active ingredient in the brand-name cholesterol-lowering drugs Altoprev and Mevacor, which are known as statins. Doctor’s Best’s Red Yeast Rice dietary supplements are not authorized by law to contain regulated active drug ingredients, and the supplement’s label does not disclose that this ingredient is in the supplement.

Consumers who use these supplements found to contain lovastatin in rare cases could experience statin side effects, which include muscle injury, liver damage, and increased blood sugar levels, especially if they are already taking a statin medication, such as the widely prescribed Lipitor. The drug could also put people, especially older women, are at greater risk of developing type 2 diabetes.

Pregnant women could also be putting their unborn child at risk by using this product as statin drugs are listed as a Category X Pregnancy Drug, meaning it should not be used during pregnancy because it could cause birth defects or death in developing fetuses. Patients with pre-existing live disease may be at an increased risk of liver injury after chronic use of statins.

Red yeast rice is a traditional Chinese medicine that some say can lower cholesterol. Several types of red yeast rice extract are sold as supplements. Though the supplements are often marketed as “natural,” buyer beware. The extract has not been studied extensively, thus the ideal dosing and long-term safety are still unknown. It could be dangerous to some people. And because the ingredients of different brands vary substantially, it is difficult to effectively gauge its effectiveness or safety, according to WebMD.

The recall involves Doctor’s Best Red Yeast Rice supplements with the UPC code of 753950001183, and the lot number 3121005 and the expiration date of February 2017. The product was sold at retail stores and online.

Any side effects with this product should be reported to the Food and Drug Administration Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA