Japanese manufacturer Kobayashi Pharmaceutical is recalling three dietary supplements that contain red yeast rice product beni-koji – it’s been linked to several cases of kidney failure, over 100 hospitalizations, and at least five deaths. Investigations as to why this red yeast rice product is causing kidney problems are still underway. This crisis is putting a spotlight on the importance of proper manufacturing practices.
Red yeast rice is primarily used to lower cholesterol. It’s created by fermenting rice with a type of yeast called Monascus purpureus. The end-product contains monacolin K, which is identical to the statin drug lovastatin. The fermentation process must be done properly in a temperature-controlled environment – red yeast rice products that are fermented incorrectly are sometimes contaminated with a toxin called citrinin. This toxin has been linked with kidney damage. Because citrinin is a known contaminant in red yeast rice, it was initially believed that this toxin might be the cause of kidney problems from the beni-koji product in Japan. But further testing hasn’t identified citrinin in these products. Rather, a compound naturally made by blue mold called puberulic acid might be the culprit, although authorities in Japan have yet to confirm.
In addition to the three products recalled by Kobayashi Pharmaceutical, the manufacturer also sold its red yeast rice to other companies throughout Japan and Taiwan – so there are ongoing concerns that many additional red yeast rice products might also be affected. Several companies have proactively recalled their products as hospitalizations and reported kidney problems continue to tick up.
We’ll keep you updated as we learn more. For now, advise patients to be very cautious as there are concerns that red yeast rice products outside of Asia might also be impacted. Additionally, tell those who take red yeast rice as an alternative to statins to talk to their healthcare provider about whether statin drugs might be more appropriate – many red yeast rice products contain the same active ingredient. Taking it in prescription form is the surest way to ensure the product isn’t contaminated.
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