| アブストラクト | BACKGROUND: Tramadol is an opioid and a serotonin reuptake inhibitor drug. It is approved for moderate to severe pain in adults. The aim of this study was to assess tramadol safety through a national pharmacovigilance study in France since dextropropoxyphen withdrawal in 2011. METHODS: We described all serious adverse drug reactions (SADRs) reported with tramadol in adults in the French National PharmacoVigilance Database from August 1st, 2011 to December 31st, 2015. RESULTS: We identified 1512 SADRs during the study period. The most frequently reported SADRs were neurological (29.4%, including troubles of consciousness [13.2%] and seizures [6.7%]), psychiatric (22.8%, including confusions [14.6%] and hallucinations [7.3%]) and gastrointestinal (17.0%, mostly nausea and vomiting [9.6%]). Unexpected SADRs were also reported: hyponatremia, cholestatic hepatitis, serotonin syndrome. CONCLUSIONS: This study demonstrates new unexpected hepatic and metabolic SADRs. Tramadol alone can induce serotonin syndrome in overdose situations. |
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| 投稿者 | Moulis, Florence; Rousseau, Vanessa; Abadie, Delphine; Masmoudi, Kamel; Micallef, Joelle; Vigier, Caroline; Pierre, Sabrina; Dautriche, Anne; Montastruc, Francois; Montastruc, Jean-Louis |
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| 組織名 | Service de pharmacologie medicale et clinique, centre Midi-Pyrenees de;pharmacovigilance, de pharmacoepidemiologie et d'informations sur le medicament,;faculte de medecine, CHU, 37, allees Jules-Guesde, 31000 Toulouse, France.;Electronic address: florence.moulis@univ-tlse3.fr.;Service de pharmacologie, centre regional de pharmacovigilance, groupe;hospitalier Pitie-Salpetriere, 75651 Paris, France.;Service de pharmacologie clinique, centre regional de pharmacovigilance d'Amiens,;CHU, 80054 Amiens, France.;Centre regional de pharmacovigilance, pharmacovigilance Marseille-Provence-Corse,;service de pharmacologie clinique et pharmacovigilance Assistance Publique -;Hopitaux de Marseille, Aix-Marseille Universite et UMR 7289 - CNRS, 13005;Marseille, France.;Service de pharmacologie clinique, centre regional de pharmacovigilance de Nice,;CHU, 06003 Nice, France.;Service de pharmacologie clinique, centre regional de pharmacovigilance de Dijon,;CHU, 21000 Dijon, France.;faculte de medecine, CHU, 37, allees Jules-Guesde, 31000 Toulouse, France;;Laboratoire de pharmacologie medicale et clinique, faculte de medecine, 31000;Toulouse, France. |
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