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 manufacturing company (Meda Pharma SpA, a Viatris Company, Monza,
Italy). From 1st October 2004 to 31st December 2019, this system captured
cases of suspected adverse reactions 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 was 542, in which 855 adverse events (AEs) were
reported. The total reporting rate of AEs was estimated to be 0.037% of
2,287,449 exposed consumers. Of the 542 cases, 21 (0.0009% of exposed
consumers) included suspected serious adverse events (SAEs). After careful
investigation, 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.ConclusionsThis nutrivigilance-derived data analysis clearly demonstrates a low prevalence of suspected
adverse events associated with the red yeast rice product line. 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 labeling.
Identification of adverse reactions to new drugs. IV--Verification of suspected adverse reactions.
