The value of time-to-onset in statistical signal detection of adverse drug reactions: a comparison with disproportionality analysis in spontaneous reports from the Netherlands

2016 ◽  
Vol 25 (12) ◽  
pp. 1361-1367 ◽  
Author(s):  
Joep H. G. Scholl ◽  
Eugène P. van Puijenbroek
Keyword(s):  
The Netherlands ◽  
Signal Detection ◽  
Adverse Drug Reactions ◽  
Value Of Time ◽  
Drug Reactions ◽  
Disproportionality Analysis ◽  
Spontaneous Reports ◽  
Statistical Signal Detection ◽  
Time To Onset

scholarly journals Risk Factor Considerations in Statistical Signal Detection: Using Subgroup Disproportionality to Uncover Risk Groups for Adverse Drug Reactions in VigiBase

Drug Safety ◽  
2020 ◽  
Vol 43 (10) ◽  
pp. 999-1009 ◽  
Author(s):  
Lovisa Sandberg ◽  
Henric Taavola ◽  
Yasunori Aoki ◽  
Rebecca Chandler ◽  
G. Niklas Norén
Keyword(s):  
Risk Factor ◽  
Signal Detection ◽  
Adverse Drug Reactions ◽  
Risk Groups ◽  
Drug Reactions ◽  
Statistical Signal Detection

A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions

2002 ◽  
Vol 11 (1) ◽  
pp. 3-10 ◽  
Author(s):  
Eug�ne P. van Puijenbroek ◽  
Andrew Bate ◽  
Hubert G. M. Leufkens ◽  
Marie Lindquist ◽  
Roland Orre ◽  
...  
Keyword(s):  
Signal Detection ◽  
Adverse Drug Reactions ◽  
Spontaneous Reporting ◽  
Drug Reactions ◽  
Reporting Systems

scholarly journals Major Aspects of Detection and Monitoring of Adverse Reactions Associated with Cephalosporin Antibiotic Treatment

2021 ◽  
Vol 9 (1) ◽  
pp. 34-42
Author(s):  
E. Yu. Demchenkova ◽  
G. I. Gorodetskaya ◽  
I. A. Mazerkina ◽  
M. V. Zhuravleva ◽  
A. S. Kazakov ◽  
...  
Keyword(s):  
Adverse Events ◽  
Adverse Drug Reactions ◽  
Patient Information ◽  
Adverse Reactions ◽  
Stevens Johnson Syndrome ◽  
Drug Reactions ◽  
Patient Information Leaflets ◽  
Information Leaflets ◽  
Spontaneous Reports ◽  
Cephalosporin Antibiotics

Widespread use of cephalosporin antibiotics in clinical practice calls for greater attention to the risk of adverse drug reactions. Information on serious or unexpected adverse events reported during post-marketing experience is submitted to national and international pharmacovigilance databases. Analysis of these reports helps to identify new adverse drug reactions.The aim of the study was to analyse the safety profile of cephalosporin antibiotics based on spontaneous reports in the international VigiBase database.Materials and methods: the analysis of the adverse reaction profile of cephalosporin antibiotics was based on MedDRA system organ classes and included spontaneous reports submitted to VigiBase from the moment of its creation until August 2020.Results: the authors identified the most clinically significant adverse reactions for different cephalosporin generations. They compared and analysed information on adverse events in VigiBase and in patient information leaflets of medicinal products authorised in the Russian Federation. It was demonstrated that some serious events described in VigiBase spontaneous reports for V-generation cephalosporins are not included in the “Side effects” section of the patient information leaflets. According to VigiBase, the use of ceftaroline was associated with the development of generalised exfoliative dermatitis, Stevens–Johnson syndrome, tubulointerstitial nephritis, while the use of ceftolozane was associated with acute kidney injury, renal insufficiency, sepsis, pneumonia, and respiratory insufficiency.Conclusion: reporting of unexpected and serious adverse drug reactions to cephalosporin antibiotics is an important task of healthcare practitioners. Availability of information on class-specific and generation-specific serious adverse reactions will help predict and prevent their development.

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