title: Drugs associated with restless legs syndrome: a case/noncase study in the French Pharmacovigilance Database.
abstract: BACKGROUND
  Several case reports have suggested that drugs could induce restless legs syndrome. However, no systematic review of this adverse drug reaction (ADR) in a pharmacovigilance database has been published.
  
  
  OBJECTIVE
  To assess the frequency of restless legs syndrome in the French Pharmacovigilance Database.
  
  
  METHODS
  We selected all ADR reports from January 1, 1984 to December 31, 2009 coded as restless legs syndrome. Restless legs syndrome diagnosis was validated from case descriptions. Using a case/noncase approach, reporting odds ratio and 95% confidence interval were calculated for "suspected'' drugs with 2 or more observations.
  
  
  RESULTS
  Twenty-six ADR reports were found. Four cases were excluded because of alternative diagnosis. Fourteen cases were women (64%). Median age was 57. Most frequently suspected drugs were antidepressants (reporting odds ratio, 15.9 [6.4-39.7]; amitriptyline, escitalopram, mianserine, mirtazapine, duloxetine), neuroleptics (17.8 [6.1-51.7]; thioridazine, loxapine, risperidone, aripiprazole) or tramadol (18.2 [6.3-52.8]).
  
  
  CONCLUSIONS
  Restless legs syndrome is a very rare ADR that was more frequently reported in association with antidepressants, neuroleptics, or tramadol.
authors.affiliation: Service de Pharmacologie Médicale et Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, Centre Hospitalier Universitaire et Université Paul Sabatier, Faculté de Médicine, Toulouse, France. splloret@fleni.org.ar
authors.forename: Santiago
authors.initials: S
authors.lastname: Perez-Lloret
authors.forename: María Verónica
authors.initials: MV
authors.lastname: Rey
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Bondon-Guitton
authors.forename: Olivier
authors.initials: O
authors.lastname: Rascol
authors.forename: And Jean-Louis
authors.initials: AJ
authors.lastname: Montastruc
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000928:Antidepressive Agents / Q000009:adverse effects; D014150:Antipsychotic Agents / Q000009:adverse effects; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions / Q000139:chemically induced* / Q000453:epidemiology*; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D060735:Pharmacovigilance; D012148:Restless Legs Syndrome / Q000139:chemically induced* / Q000453:epidemiology*; D014147:Tramadol / Q000009:adverse effects; D055815:Young Adult
chemical_list: D000928:Antidepressive Agents; D014150:Antipsychotic Agents; D014147:Tramadol