Trends of reporting of ‘serious’vs. ‘non-serious’ adverse drug reactions over time: a study in the French PharmacoVigilance Database
Article first published online: 11 JUN 2012
© 2012 The Authors. British Journal of Clinical Pharmacology © 2012 The British Pharmacological Society
British Journal of Clinical Pharmacology
Volume 74, Issue 1, pages 201–204, July 2012
How to Cite
Moulis, G., Sommet, A., Durrieu, G., Bagheri, H., Lapeyre-Mestre, M., Montastruc, J.-L. and The French Association of PharmacoVigilance Centres (2012), Trends of reporting of ‘serious’vs. ‘non-serious’ adverse drug reactions over time: a study in the French PharmacoVigilance Database. British Journal of Clinical Pharmacology, 74: 201–204. doi: 10.1111/j.1365-2125.2012.04185.x
- Issue published online: 11 JUN 2012
- Article first published online: 11 JUN 2012
- Accepted manuscript online: 18 JAN 2012 10:53AM EST
- Received; 8 August 2011; Accepted; 25 December 2011; Accepted Article Published Online; 18 January 2012
- ‘serious’ adverse drug reactions;
- adverse drug reactions;
- spontaneous reporting
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT
• Several factors are known to influence spontaneous reporting of adverse drug reactions (ADRs). Among them, ‘seriousness’ of the reaction is one of the most important.
• However, evolution in the reporting of ‘serious’vs.‘non-serious’ ADRs over time for the same drug remains unknown.
WHAT THIS STUDY ADDS
• Spontaneous reports mainly involve ‘non-serious’ ADRs during the first years of marketing and ‘serious’ ADRs later, particularly for drugs with non-hospital use.
AIM To investigate trends in spontaneous reporting to the French Pharmacovigilance system of ‘serious’ (SADRs) and ‘non-serious’ (NSADRs) adverse drug reactions over time.
METHODS Annual SADR : NSADR ratios were calculated for each drug and their evolution tested with linear trend tests.
RESULTS Among the 39 new active substances commercialized in France in 2000, 16 had sufficient data to perform linear trend tests. An increasing linear relation was found for five widely prescribed drugs, a non-significant increasing trend for eight others, i.e. drugs mostly used in hospitals.
CONCLUSION ADR reports mainly concern NSADRs during first years of marketing. Reports of SADRs are proportionally more frequent later.