Search results for "nutrivigilance"
showing 3 items of 3 documents
Avis de l'Anses relatif à l'actualisation de la méthode d'imputabilité des signalements d'effets indésirables de nutrivigilance
2019
A l’instar des autres systèmes de vigilance français et compte tenu de l’importance des conséquences en matière de santé et des décisions industrielles qui en découlent, l’analyse de la relation de causalité entre un produit visé par le dispositif national de nutrivigilance et l’effetindésirable déclaré doit être réalisée avec une méthode d’analyse appropriée et objective. Cette méthode dite « méthode d’imputabilité de nutrivigilance » estime le degré de causalité, d’un ou de plusieurs produits dans la survenue de l’effet indésirable déclaré, de manière standardisée, permettant d’éliminer les divergences d’opinion pouvant exister entre plusieurs observateurs. De telles méthodes sont couramm…
Drug Induced Liver Injury (DILI) due to variability in monacolin K content in Red Yeast Rice (RYR): An expert opinion
2020
Abstract Introduction Red yeast rice (RYR) is an effective cholesterol-lowering nutraceutical reversibly inhibiting 3-hydroxy-3-methyl-glutaryl-CoA (HMG-CoA) reductase. As liver damage is a possible (albeit rare) side effect of HMG-CoA inhibitors, it make sense to focus on the tolerability of the liver to RYR extracts. The aim of this paper is to offer an expert opinion on the risk of liver damage by the use of RYR extract. Methods A review of the available literature has been carried out and critically reviewed by the authors. Results According to a large meta-analysis of 53 randomized clinical trials comprising 112 treatment arms, which included 8535 subjects with 4437 in the RYR arm and …
Postmarketing nutrivigilance safety profile: a line of dietary food supplements containing red yeast rice for dyslipidemia
2021
IntroductionIn the absence of a European standardized postmarketing food supplement surveillance system (nutrivigilance), some member states and companies have developed their own approaches to monitoring potential adverse reactions to secure a high level of product safety. This paper describes the use of a nutrivigilance system in monitoring the incidence of spontaneously reported suspected adverse reactions associated with food supplements containing red yeast rice (RYR).Material and methodsWe report the data from a widely used product marketed under the trademark Armolipid/Armolipid Plus. Postmarketing information was collected in a voluntary nutrivigilance system established by the manu…