title: ["Serious" adverse drug reactions with tramadol: a 2010-2011 pharmacovigilance survey in France].
abstract: OBJECTIVE
  Tramadol is a weak opioid used as a step 2 analgesic, approved in France for moderate to severe pain. After dextropropoxyphene withdrawal, a national pharmacovigilance follow-up of tramadol was decided by the French Drug Agency.
  
  
  METHODS
  All Serious Adverse Drug Reactions (SADR) notified with tramadol to the French PharmacoVigilance Centres (CRPV) and pharmaceutical companies between August 1(st), 2010 and July 31(th), 2011 were analyzed.
  
  
  RESULTS
  During the study period, 296 cases of SADR were notified to CRPV and 59 to pharmaceutical companies. Apart from opiate-related SADR, tramadol induced serotoninergic SADR, including seizures or serotoninergic syndromes. Several « unlabelled » SADR were also identified: some of them, like hyponatremia or hypoglycemia, are poorly known by health professionals. Other were never published: peripheral edema or pancreatitis.
  
  
  CONCLUSIONS
  This study shows that besides well-known opioid or serotoninergic ADR, tramadol can also induce 2 other relatively unknown ADR: hypoglycemia and hyponatremia.
authors.affiliation: Laboratoire de Pharmacologie Médicale et Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'Informations sur le Médicament, et Centre Midi-Pyrénées d'Évaluation et d'Information sur la Pharmacodépendance-Addictovigilance, Université de Toulouse, Faculté de Médecine, Centre hospitalier universitaire, Toulouse, France. dabadie@cict.fr
authors.forename: Delphine
authors.initials: D
authors.lastname: Abadie
authors.forename: Geneviève
authors.initials: G
authors.lastname: Durrieu
authors.forename: Anne
authors.initials: A
authors.lastname: Roussin
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Montastruc
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000701:Analgesics, Opioid / Q000009:adverse effects*; D004345:Drug Industry; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005602:France; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000453:epidemiology; D007010:Hyponatremia / Q000139:chemically induced / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D060735:Pharmacovigilance; D014147:Tramadol / Q000009:adverse effects*
chemical_list: D000701:Analgesics, Opioid; D014147:Tramadol