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Dietary supplements made from red yeast rice contain substances called monacolins, which are similar to the active ingredient in cholesterol-lowering statin drugs. And like statins, red yeast rice products may cause rare but serious side effects, such as muscle injury and liver damage, as noted in a study published online January 19, 2017, by the British Journal of Pharmacology.
The study, based on a review of 13 years of patient data by Italian researchers, notes that people who can't tolerate statins often take red yeast rice supplements. But there are no studies testing the safety of red yeast rice compared with statins. In the United States, the FDA considers red yeast rice products that contain more than trace amounts of monacolins to be unapproved new drugs and therefore illegal to sell. Yet dozens of these unregulated products remain on the market.
Among the 55 reported adverse reactions from red yeast rice products, most involved muscle pain, gastrointestinal problems, and liver injury, and 13 people had to be hospitalized. Taking a statin under a doctor's supervision is safer, as both the drug dosage and any side effects can be monitored.