See the results of the largest ever #reallife analysis on red yeast rice (#RYR) preparations’ #safety (2.3 million #consumers). We confirmed that RYR is very safe – the total reporting rate of #AEs was estimated to be 0.037%. Of the 542 reported cases, 21 (0.0009% of exposed consumers) included suspected serious adverse events (#SAEs). After careful investigation, only 6 cases (0.0003% of consumers exposed) and 6 AEs were assessed by the manufacturer as serious and potentially related to exposure to the above-mentioned RYR-based #nutraceutical.
It is not only a strong argument for the RYR safety, but also a critical information for natural products (#supplements, functional #foods, nutraceuticals) manufacturers that #quality of production, and especially safety #monitoring (#nutrivigilance) should be proceeded similarly to #drugs in order to avoid similar discussions as we have had in last 3 years whether RYR (monoklin K/ natural lovastatin) at the dose of 3 mg is safe.