Could Decreased Reporting of Suspected Adverse Reactions Generate Future Safety Concerns?

2022 ◽  
pp. 001857872110690
Author(s):  
Francesco Ferrara ◽  
Carolina Mancaniello ◽  
Livia Nava ◽  
Alessandra Salierno ◽  
Raffaele Casillo ◽  
...  
Keyword(s):  
Adverse Reactions ◽  
Safety Concerns ◽  
Suspected Adverse Reactions

Suspected adverse reactions, 2007

2008 ◽  
Vol 163 (3) ◽  
pp. 69-72 ◽  
Author(s):  
F. Dyer ◽  
M. Spagnuolo-Weaver ◽  
S. Cooles ◽  
A. Tait
Keyword(s):  
Adverse Reactions ◽  
Suspected Adverse Reactions

scholarly journals Postmarketing nutrivigilance safety profile: a line of dietary food supplements containing red yeast rice for dyslipidemia

2021 ◽  
Author(s):  
Maciej Banach ◽  
Niki Katsiki ◽  
Gustavs Latkovskis ◽  
Manfredi Rizzo ◽  
Daniel Pella ◽  
...  
Keyword(s):  
Adverse Events ◽  
Adverse Reactions ◽  
Case Reports ◽  
Food Supplement ◽  
Product Line ◽  
Food Supplements ◽  
Red Yeast Rice ◽  
Red Yeast ◽  
Consumer Safety ◽  
Suspected Adverse Reactions

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.

A Clinicopathological Study of Metal-on-Metal Hips Revised for Suspected Adverse Reactions to Metal Debris

2013 ◽  
pp. 53-66
Author(s):  
Gulraj S. Matharu ◽  
Matthew P. Revell ◽  
Vaiyapuri Sumathi ◽  
Paul B. Pynsent ◽  
Peter A. Revell
Keyword(s):  
Adverse Reactions ◽  
Metal Debris ◽  
Metal On Metal ◽  
Clinicopathological Study ◽  
Suspected Adverse Reactions

Suspected adverse reactions to contrast media in Campania Region (Italy): results from 14 years of post-marketing surveillance

2015 ◽  
Vol 14 (9) ◽  
pp. 1341-1351 ◽  
Author(s):  
Maurizio Sessa ◽  
Claudia Rossi ◽  
Annamaria Mascolo ◽  
Enrico Grassi ◽  
Sonia Fiorentino ◽  
...  
Keyword(s):  
Contrast Media ◽  
Adverse Reactions ◽  
Campania Region ◽  
Post Marketing Surveillance ◽  
Suspected Adverse Reactions ◽  
Post Marketing
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