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Journal ArticleOpen Access

Surveillance of adverse events in the treatment of drug-resistant tuberculosis: first global report

Author Affiliations
Government of Russia, Vilnius University, Northern State Medical University, Ministério da Saúde, ...
Published InEuropean Respiratory Journal
Year2019
Citations175

Abstract

The World Health Organization (WHO) recommends that countries implement pharmacovigilance and collect information on active drug safety monitoring (aDSM) and management of adverse events. The aim of this prospective study was to evaluate the frequency and severity of adverse events to anti-tuberculosis (TB) drugs in a cohort of consecutive TB patients treated with new ( i.e. bedaquiline, delamanid) and repurposed ( i.e. clofazimine, linezolid) drugs, based on the WHO aDSM project. Adverse events were collected prospectively after attribution to a specific drug together with demographic, bacteriological, radiological and clinical information at diagnosis and during therapy. This interim analysis included patients who completed or were still on treatment at time of data collection. Globally, 45 centres from 26 countries/regions reported 658…
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