title: Trends of reporting of 'serious'vs. 'non-serious' adverse drug reactions over time: a study in the French PharmacoVigilance Database.
abstract: BACKGROUND
  • 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.
  
  
  CONCLUSIONS
  • Spontaneous reports mainly involve 'non-serious' ADRs during the first years of marketing and 'serious' ADRs later, particularly for drugs with non-hospital use.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  ADR reports mainly concern NSADRs during first years of marketing. Reports of SADRs are proportionally more frequent later.
authors.affiliation: CHU Toulouse, Service de Pharmacologie Clinique, Centre Midi-Pyrénées de PharmacoVigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Toulouse, F-31059, France. guillaume.moulis@univ-tlse3.fr
authors.forename: Guillaume
authors.initials: G
authors.lastname: Moulis
authors.forename: Agnès
authors.initials: A
authors.lastname: Sommet
authors.forename: Geneviève
authors.initials: G
authors.lastname: Durrieu
authors.forename: Haleh
authors.initials: H
authors.lastname: Bagheri
authors.forename: Maryse
authors.initials: M
authors.lastname: Lapeyre-Mestre
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Montastruc
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000639:trends*; D001291:Attitude of Health Personnel; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions / Q000145:classification*; D005602:France; D006801:Humans; D060735:Pharmacovigilance; D013997:Time Factors