Trends of reporting of 'serious'vs. 'non-serious' adverse drug reactions over time: A study in the French PharmacoVigilance Database

Abstract

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. © 2012 The Authors. British Journal of Clinical Pharmacology © 2012 The British Pharmacological Society.