麻豆传媒

Red yeast rice supplements, popular for lipid lowering, may have liver and muscle risks "highly similar to that of synthetic statins," according to analysis of an Italian surveillance program for natural health remedies -- most likely because its active ingredient is an actual statin.

The contains -- a naturally-occurring compound to lovastatin (Altocor, Mevacor) -- "and is often proposed as an alternative therapy in statin-intolerant patients," , of Sapienza University of Rome, and colleagues noted in the study published online in the British Journal of Clinical Pharmacology.

But the common perception that natural is safer didn't pan out in the study of the Italian Surveillance System of Natural Health Products, similar to the findings of a prior French government analysis of adverse event reports it received on red yeast rice.

The Italian database included among the total 1,261 reports received from April 2002 to September 2015.

Those events were most commonly myalgia and/or increase in creatine phosphokinase (19 events), liver injury (10 events), or gastrointestinal reactions (12 events), but there was one case of rhabdomyolysis as well as nine cutaneous reactions and four "other" reactions. Among them, 13 required hospitalization.

The multidisciplinary team using two strategies to assess causality noted that stopping red yeast rice resolved the event in 73% of the cases, while rechallenge was positive in seven of the cases. Causality was determined to certain in one case, probable in 56% and possible in another 34%.

"The proportion of serious reports (27%), the relatively rapid time to onset and the lack of concomitant drugs and/or predisposing medications in several cases warrants regulatory consideration," the researchers concluded, "and call for: 1) continuous monitoring of 'natural' dietary supplements safety through spontaneous reports; 2) appropriate information to clinicians and consumers, who should timely submit suspect reports to regulatory Agencies."

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