title: Bleeding adverse drug reactions (ADRs) in patients exposed to antiplatelet plus serotonin reuptake inhibitor drugs: analysis of the French Spontaneous Reporting Database for a controversial ADR.
abstract: OBJECTIVE
  The aim of the present study was to investigate bleeding adverse drug reactions (ADRs) in patients exposed to serotonin reuptake inhibitors (SRI) plus antiplatelet agents using the French Pharmacovigilance Database (FPVDB) regarding the controversial data in the literature.
  
  
  METHODS
  The case/non-case method was used to measure the association between bleedings and exposure to SRIs plus antiplatelet agents versus antiplatelet drugs alone.
  
  
  RESULTS
  Over 3 years, a total of 1,977 spontaneous reports of ADRs were collected with antiplatelet drugs, and antiplatelet agents plus SRIs in patients aged over 50 years, of which 1,331 (67.3 %) concerned bleeding. Multivariate logistic regression analysis failed to show any significant association [adjusted ROR = 0.8 (0.5-1.2)].
  
  
  CONCLUSIONS
  The data did not demonstrate any significant association between bleeding ADRs and exposure to SRI + antiplatelet agents versus antiplatelets alone. Considering other conflicting results, this risk should be kept in mind by physicians when treating patients with several risk factors.
authors.affiliation: Service de Pharmacologie Clinique, Equipe de Pharmacoépidémiologie, INSERM U 1027, Faculté de Médecine, Université de Toulouse, 37 allées Jules Guesde, 31000, Toulouse, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Maschino
authors.forename: Caroline
authors.initials: C
authors.lastname: Hurault-Delarue
authors.forename: Leila
authors.initials: L
authors.lastname: Chebbane
authors.forename: Vincent
authors.initials: V
authors.lastname: Fabry
authors.forename: Jean Louis
authors.initials: JL
authors.lastname: Montastruc
authors.forename: Haleh
authors.initials: H
authors.lastname: Bagheri
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects; D016022:Case-Control Studies; D002543:Cerebral Hemorrhage / Q000139:chemically induced / Q000453:epidemiology; D004347:Drug Interactions; D005260:Female; D005602:France / Q000453:epidemiology; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced / Q000453:epidemiology; D006470:Hemorrhage / Q000139:chemically induced* / Q000453:epidemiology; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects*; D012307:Risk Factors; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D010975:Platelet Aggregation Inhibitors; D017367:Selective Serotonin Reuptake Inhibitors