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Safety of Ankascin

Red Yeast Rices

Long-term use of statins, or of red yeast rice containing monacolin K, produces toxic side effects on the liver, kidneys, and skeletal muscle.

These side effects are worsened by interactions with drugs that increase the biological activity of statins (see Table 1)45. Toxicity is a major reason why patients discontinue statin therapy, which in the absence of a suitable replacement leaves these patients at a high risk of heart attacks or strokes. Ankascin red yeast rice is statin-free, and has no reported side effects. Evidence for this safety comes from clinical trials, in which patients receiving Ankascin were monitored carefully for signs of toxicity.

Blood tests were conducted for aspartate aminotransferase and alanine aminotransferase.

These are liver enzymes that are released into the blood when the liver is damaged. In all clinical studies, blood levels of these enzymes remained normal.

The scientists involved in these clinical studies also tested for creatine phosphokinase, which is released from skeletal muscle upon damage, and for creatinine and various electrolytes that are elevated with kidney damage. Levels of all these metabolites remained normal, even with treatments lasting up to 10 months

These results show that, unlike statins and other red yeast rice supplements, use of Ankascin comes with no toxic side effects.

Ankascin red yeast rice is on the FDA’s list of New Dietary Ingredients14. To be included on this list, a manufacturer must demonstrate that the product is reasonably expected to be safe.

Safety Tests for Ankascin Included the Following:

  • 90-day oral toxicity study in rats, at 230 times the usual dosage
  • In vitro chromosomal aberration assay, to determine if it is carcinogenic
  • Micronucleus assay, to determine if it is genotoxic
  • Ames test, to also determine genotoxicity

All of these tests were negative for Ankascin, providing further evidence of its safety for sustained use.

INTERACTING DRUGS AND SUBSTANCES

ITRACONAZOLE

CYCLOSPORINE

DILTIAZEM

KETOCONAZOLE

POSACONAZOLE

BOCEPREVIR

TELAPREVIR

ERYTHROMYCIN

NEFAZODONE

GRAPEFRUIT JUICE

Table 1. Partial list of drugs and substances that interact with statins such as monacolin K. None of these interaction apply to Ankascin red yeast rice.

REFERENCE

14. FDA Center for Food Safety and Applied Nutrition. Letter from FDA CFSAN to Sunway Biotech Company, Ltd regarding NDI 855- Ankascin 568-R. https://www.regulations.gov/document?D=FDA-2015-S-0023-0004. 

45. Bellosta, S. and Corsini, A. (2018). Statin drug interactions and related adverse reactions: an update. Expert Opinion on Drug Safety 17: 25–37.

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Ph.D

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