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• W2016650487 abstract "Le tramadol est un opioïde de palier 2 indiqué en France dans les douleurs modérées à sévères. Une enquête nationale de pharmacovigilance a été mise en place après le retrait du dextropropoxyphène. Nous avons analysé les notifications françaises d’effets indésirables « graves » (EIG) imputées au tramadol et parvenues aux Centres régionaux de pharmacovigilance (CRPV) ou aux firmes pharmaceutiques entre le 1er août 2010 et le 31 juillet 2011. Durant la période d’enquête, 296 cas d’EIG ont été notifiés aux CRPV et 59 aux firmes. Outre les EI opioïdes, nous avons identifié plusieurs EI sérotoninergiques, dont des convulsions et des syndromes sérotoninergiques. Nous avons aussi mis en évidence des EI « inattendus », certains méconnus des professionnels de santé (hypoglycémie, hyponatrémie), d’autres n’ayant jamais fait l’objet de publications (œdèmes des membres inférieurs, pancréatites). Ce suivi montre qu’à côté des EI opioïdes ou sérotoninergiques bien décrits, le tramadol peut aussi déterminer 2 autres EI relativement peu connus : hypoglycémie et hyponatrémie. 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. All Serious Adverse Drug Reactions (SADR) notified with tramadol to the French PharmacoVigilance Centres (CRPV) and pharmaceutical companies between August 1st, 2010 and July 31th, 2011 were analyzed. 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. This study shows that besides well-known opioid or serotoninergic ADR, tramadol can also induce 2 other relatively unknown ADR: hypoglycemia and hyponatremia." @default.
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• W2016650487 date "2013-03-01" @default.
• W2016650487 modified "2023-10-18" @default.
• W2016650487 title "Effets indésirables « graves » du tramadol : bilan 2010-2011 de pharmacovigilance en France" @default.
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• W2016650487 doi "https://doi.org/10.2515/therapie/2013021" @default.
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