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Therapie. 2013 Mar-Apr;68(2):77-84. doi: 10.2515/therapie/2013021. Epub 2013 Jun 18.

["Serious" adverse drug reactions with tramadol: a 2010-2011 pharmacovigilance survey in France].

[Article in French]

Author information

1
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

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.

CONCLUSION:

This study shows that besides well-known opioid or serotoninergic ADR, tramadol can also induce 2 other relatively unknown ADR: hypoglycemia and hyponatremia.

PMID:
23773348
DOI:
10.2515/therapie/2013021
[Indexed for MEDLINE]

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