2024 Update on Postmarketing Nutrivigilance Safety Profile: A Line of Dietary Food Supplements Containing Red Yeast Rice for Dyslipidemia.

Abstract

IntroductionConsidering lack of a European standardized postmarketing food supplement surveillance system, some member states and companies have developed their own approaches to monitoring potential AEs to secure a high level of product safety. This paper updates 2021 results of the use of a nutrivigilance system in monitoring the incidence of spontaneously reported suspected AEs associated with RYR-containing food supplements.Material and methodsWe report the data from a product marketed under the trademark Armolipid/Armolipid Plus. Postmarketing information was collected in a voluntary nutrivigilance system established by the manufacturing company (Meda Pharma SpA, a Viatris Company, Monza, Italy). From 1st October 2004-31st December 2023, this system captured cases of suspected AEs spontaneously reported by consumers, healthcare professionals, health authorities, regardless of causality.ResultsThe total number of case reports received mentioning the RYR-food supplement product line increased to 1186, in which 1904 AEs were reported. The total reporting rate of AEs was estimated to be 0.049% of 3,880,865 exposed consumers. Of the 1186 cases, 28 (0.0007%) included suspected SAEs. After careful investigation, 9 cases (0.0002%) and 12 AEs were assessed by the manufacturer as serious and potentially related to exposure to the above-mentioned RYR-based nutraceutical. Off-label reports linked to the newly introduced limitation at 70 years of age were observed, in contrast to the previous analysis.ConclusionsThese updated results confirm a very low incidence of RYR suspected AEs. Consumer safety of food supplements could be generally improved by raising awareness of the importance of following the indications and warnings detailed in a food supplement’s labelling.