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Adverse drug reactions of analgesic medicines: analysis of the Romanian pharmacovigilance database

dc.rights.licenseopenen_US
dc.contributor.authorCAZACU, I.
dc.contributor.authorSTROE, R.
dc.contributor.authorDONDERA, R.
dc.contributor.authorMOGOSAN, C.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorHARAMBURU, Francoise
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorFOURRIER-REGLAT, Annie
dc.contributor.authorLOGHIN, F.
dc.date.accessioned2020-10-27T14:23:04Z
dc.date.available2020-10-27T14:23:04Z
dc.date.issued2018-06
dc.identifier.issn0767-3981en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/11512
dc.description.abstractEnThe results of national safety studies are essential for decision-making at the regulatory level and have also educational implications for prescribing patterns. The aim of this study was to analyze the adverse drug reactions (ADRs) of analgesic medicines spontaneously reported to Pharmacovigilance and Risk Management Service of the Romanian National Agency for Medicines and Medical Devices between 2011 and 2015. For the 71 reports, patients had a mean age of 39.8 years; 60.6% of patients were female, and 38% male and 1.4% were unknown. Reporters were mainly physicians (74.7%), and 52.1% of ADR reports were transmitted through marketing authorization holders. Of the serious ADRs (32.4%), 34.7% led to hospitalization or prolonged hospitalization. The most frequent ADRs reported were skin and subcutaneous tissue disorders (25.8%) and general disorders and administration site conditions (19.2%). Metamizole, alone or in combination, was the main analgesic suspected in almost 15.5% of the cases and remains one of the most popular analgesics in Romania. Ten cases were assessed as preventable or potentially preventable (14%), of which two cases were serious. Even if the level of reporting is still low, this study conducted on ADRs of analgesics reported to the national pharmacovigilance center represents an essential step toward promoting the rational use of analgesics in Romania.
dc.language.isoENen_US
dc.subject.enPharmacoEpi-Drugs
dc.title.enAdverse drug reactions of analgesic medicines: analysis of the Romanian pharmacovigilance database
dc.title.alternativeFundam Clin Pharmacolen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1111/fcp.12343en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed29314262en_US
bordeaux.journalFundamental & clinical pharmacologyen_US
bordeaux.page330-336en_US
bordeaux.volume32en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - U1219en_US
bordeaux.issue3en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-02980580
hal.version1
hal.date.transferred2020-10-27T14:23:09Z
hal.exporttrue
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