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Therapie. 2017 Dec;72(6):615-624. doi: 10.1016/j.therap.2017.03.004. Epub 2017 Jun 29.

[Serious adverse drug reactions with tramadol reported to the French pharmacovigilance database between 2011 and 2015].

[Article in French]

Author information

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.

KEYWORDS:

Cholestase; Cholestasis; Drug-related side effects and adverse reactions; Effets secondaires indésirables des médicaments; Serotonin syndrome; Syndrome sérotoninergique; Tramadol

PMID:
28755832
DOI:
10.1016/j.therap.2017.03.004
[Indexed for MEDLINE]

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