scholarly journals Guideline on management of suspected adverse reactions to ingested histamine - Guideline of the German Society for Allergology and Clinical Immunology (DGAKI), the Society for Pediatric Allergology and Environmental Medicine (GPA), the Medical Association

2021 ◽  
Vol 5 (01) ◽  
pp. 305-314
Author(s):  
Imke Reese ◽  
Barbara Ballmer-Weber ◽  
Kirsten Beyer ◽  
Sabine Dölle-Bierke ◽  
Jörg Kleine-Tebbe ◽  
...  
Keyword(s):  
Medical Association ◽  
Environmental Medicine ◽  
Clinical Immunology ◽  
Adverse Reactions ◽  
German Society ◽  
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

The Registry on Adverse Reactions of the American Medical Association

1965 ◽  
Vol 04 (01) ◽  
pp. 15-21
Author(s):  
Norman De Nosaquo
Keyword(s):  
American Medical Association ◽  
Medical Association ◽  
American Medical ◽  
Adverse Reactions ◽  
Exchange Of Information ◽  
The World ◽  
Relationship Of ◽  
Methods Of Operation

The events which led to the development by the American Medical Association of an overall Registry on Adverse Reactions are described. The methods of operation involving reporting, collating, and disseminating information on adverse reactions to drugs and chemicals are outlined. A chart showing the organizational relationship of the Registry to the Council on Drugs is given. Copies of the report form, the guide for reporting, the code sheet, and the coding guide are presented. The author recommends that similar activities be undertaken in order to facilitate a free exchange of information throughout the world.

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