Journal article

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

Sergey Borisov, Edvardas Danila, Andrei Maryandyshev, Margareth Dalcolmo, Skaidrius Miliauskas, Liga Kuksa, Selene Manga, Alena Skrahina, Saulius Diktanas, Luigi Ruffo Codecasa, Alena Aleksa, Judith Bruchfeld, Antoniya Koleva, Alberto Piubello, Zarir Farokh Udwadia, Onno W Akkerman, Evgeny Belilovski, Enrique Bernal, Martin J Boeree, Julen Cadinanos Loidi Show all

European Respiratory Journal | EUROPEAN RESPIRATORY SOC JOURNALS LTD | Published : 2019

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..

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Funding Acknowledgements

The project is supported by the Global Tuberculosis Network (GTN; Committees on TB Treatment, Clinical Trials and Global TB Consilium) and was part of the European Respiratory Society Latin American project in collaboration with ALAT (Asociacion Latino Americana de Torax -Latino American Thoracic Association) and SBPT (Brazilian Society of Pulmonology and Tuberculosis). This article belongs to the scientific activities of the WHO Collaborating Centre for Tuberculosis and Lung Diseases, Tradate, ITA-80, 2017-2020-GBM/RC/LDA.