| アブストラクト | Adverse drug reactions (ADR) significantly impact mortality and morbidity and lead to high healthcare costs. Reporting ADR to regulatory authorities allows for monitoring the safety and efficacy profile of medicines on the market and for assessing the benefit-risk ratio. This retrospective study aims to characterize the ADR profile of the most consumed antibiotics in Portugal that are prescribed for upper airway infections and submitted to the EudraVigilance database. The variables were analyzed in an exploratory perspective, through absolute and relative frequencies, with emphasis on serious ADR. A total of 59,022 reports were analyzed of which 64.4% were classified as suspected serious ADR. According to serious ADR, the female sex (52.2%) and 18-64 age group (47.5%) prevail. Health professionals reported 87.8% of suspected serious ADR and European Economic Area (EEA) countries represented 50.8% of the reports. "Skin and subcutaneous tissue connections" (15.9%), "general disorders and administrations site conditions" (12%), and "gastrointestinal disorders" (9.8%) are the prevalent system organ classes. In 4.5% of the reports, patients had a fatal outcome. A periodic evaluation of the safety of the antibiotic should be performed to facilitate the development of guidelines and policies to reduce the frequency of serious ADR. |
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| 組織名 | NOVA Medical School, Faculty of Medical Sciences, New University of Lisbon;(NMS|FCM UNL), 1169-056 Lisbon, Portugal.;Research Unit for Inland Development, Polytechnic of Guarda (UDI-IPG), 6300-559;Guarda, Portugal.;Center for Research & Development in Mathematics and Application (CIDMA),;University of Aveiro, 3810-193 Aveiro, Portugal.;Porto Pharmacovigilance Centre, Faculty of Medicine, University of Porto,;4200-450 Porto, Portugal.;Center for Health Technology and Services Research (CINTESIS), Faculty of;Medicine, University of Porto, 4200-450 Porto, Portugal.;MEDCIDS-Department of Community Medicine, Health Information and Decision,;Faculty of Medicine, University of Porto, 4200-450 Porto, Portugal.;Health Sciences Research Centre, University of Beira Interior (CICS-UBI),;6200-506 Covilha, Portugal.;Institute of Biomedicine, Department of Medical Sciences, University of Aveiro,;3810-193 Aveiro, Portugal. |
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