Florence Moulis1, Vanessa Rousseau2, Delphine Abadie3, Kamel Masmoudi4, Joëlle Micallef5, Caroline Vigier6, Sabrina Pierre7, Anne Dautriche7, François Montastruc8, Jean-Louis Montastruc8. 1. Service de pharmacologie médicale et clinique, centre Midi-Pyrénées de pharmacovigilance, de pharmacoépidémiologie et d'informations sur le médicament, faculté de médecine, CHU, 37, allées Jules-Guesde, 31000 Toulouse, France. Electronic address: florence.moulis@univ-tlse3.fr. 2. Service de pharmacologie médicale et clinique, centre Midi-Pyrénées de pharmacovigilance, de pharmacoépidémiologie et d'informations sur le médicament, faculté de médecine, CHU, 37, allées Jules-Guesde, 31000 Toulouse, France. 3. Service de pharmacologie, centre régional de pharmacovigilance, groupe hospitalier Pitié-Salpêtrière, 75651 Paris, France. 4. Service de pharmacologie clinique, centre régional de pharmacovigilance d'Amiens, CHU, 80054 Amiens, France. 5. Centre régional de pharmacovigilance, pharmacovigilance Marseille-Provence-Corse, service de pharmacologie clinique et pharmacovigilance Assistance Publique - Hopitaux de Marseille, Aix-Marseille Université et UMR 7289 - CNRS, 13005 Marseille, France. 6. Service de pharmacologie clinique, centre régional de pharmacovigilance de Nice, CHU, 06003 Nice, France. 7. Service de pharmacologie clinique, centre régional de pharmacovigilance de Dijon, CHU, 21000 Dijon, France. 8. Service de pharmacologie médicale et clinique, centre Midi-Pyrénées de pharmacovigilance, de pharmacoépidémiologie et d'informations sur le médicament, faculté de médecine, CHU, 37, allées Jules-Guesde, 31000 Toulouse, France; Laboratoire de pharmacologie médicale et clinique, faculté de médecine, 31000 Toulouse, France.
Abstract
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.
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.
Authors: David L Murphy; Jacob A Lebin; Stevan G Severtson; Heather A Olsen; Nabarun Dasgupta; Richard C Dart Journal: Drug Saf Date: 2018-08 Impact factor: 5.606
Authors: Jorge Enrique Machado-Alba; Laura Sofía Serna-Echeverri; Luis Fernando Valladales-Restrepo; Manuel Enrique Machado-Duque; Andrés Gaviria-Mendoza Journal: Pain Res Manag Date: 2020-11-20 Impact factor: 3.037
Authors: Marwa H Bakr; Eman Radwan; Asmaa S Shaltout; Alshaimaa A Farrag; Amany Refaat Mahmoud; Tarek Hamdy Abd-Elhamid; Maha Ali Journal: Sci Rep Date: 2021-09-21 Impact factor: 4.379