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Utilize este identificador para referenciar este registo: http://hdl.handle.net/10314/7093

Título: Descriptive Analysis of Adverse Drug Reactions Reports of the Most Consumed Antibiotics in Portugal, Prescribed for Upper Airway Infections
Autores: Ferreira, Joana
Plácido, Ana
Afreixo, Vera
Ribeiro-Vaz, Inês
Roque, Fátima
Herdeiro, Maria
Palavras Chave: EudraVigilance database
adverse drug reactions
antibiotics
upper airway infections
Data: 2-Apr-2022
Resumo: 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.
URI: http://hdl.handle.net/10314/7093
ISSN: 35453228
Aparece nas Colecções:Artigos em Revista Internacional (ESS)

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