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Japanese authorities on Wednesday ordered drugmaker Kobayashi Pharmaceutical to recall three dietary supplement products containing red yeast rice, or beni koji, after they were linked to two deaths.
The Kobayashi red yeast rice scandal (Japanese: 小林製薬紅麹サプリメント問題) is an ongoing widespread supplement contamination that was first noted on 22 March 2024, resulting in numerous health problems to people taking the supplements in Japan and Taiwan. Up to 80 people died after taking the supplements, with at least 500 more ...
In 1998, the FDA placed a ban on the sale of dietary supplements derived from red yeast rice, which naturally contains lovastatin, arguing that products containing prescription agents require drug approval. [38]
Red yeast rice or red rice koji is a bright reddish purple fermented rice, which acquires its color from being cultivated with the mold Monascus purpureus.Red yeast rice is what is referred to as a kōji in Japanese, meaning "grain or bean overgrown with a mold culture", a food preparation tradition going back to ca. 300 BC.
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The prescription drug Lovastatin, identical to monacolin K, is the principal statin produced by M. purpureus. Only the open-ring (hydroxy acid) form is pharmacologically-active, but it is not produced on a commercial scale.
In reference to: "ConsumerLab.com found large variation in the active compounds between red yeast rice supplements, and also found that some of them were contaminated with citrinin, a nephrotoxic mycotoxin.[2][3] Evidence about the side effects of red yeast rice is limited, but it may have similar side effects to the drug lovastatin, which ...
The U.S. Food and Drug Administration (FDA) notified healthcare professionals of updates to the prescribing information concerning interactions between protease inhibitors and certain statin drugs. Protease inhibitors and statins taken together may increase the blood levels of statins and increase the risk for muscle injury (myopathy).