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Monitoring of safety using favipiravir: risk management of adverse drug reactions in clinical practice

https://doi.org/10.37489/2588-0519-2020-S4-115-119

Abstract

Global experience with the clinical use of favipiravir is very limited. Its safety is for further study. Prevention of teratogenic effects (mandatory pregnancy test before starting therapy, compliance with effective contraception by both women and men), control of the level of uric acid, transaminases and ECG are of fundamental importance. Alertness is needed for new, insufficiently documented or previously unreported adverse events such as motor disturbances and falls. Patients should be fully informed about all the risks of therapy before starting it. Special attention is required to timely fill out the approved forms of notifications on the development of HP and report them in time according to the Order of the Federal Service for Surveillance in Healthcare of February 15, 2017 No. 1071 «On approval of the Procedure for the implementation of pharmacovigilance.»

About the Authors

Yu. Yu. Kiselev
Oslo Metropolitan University
Norway

Kiselev Yuri Yu. – PhD, Associate Professor at the Faculty of Health Sciences OsloMet

Oslo



A. V. Matveev
Russian Medical Academy of Continuing Professional Education of the Ministry of Health of Russia
Russian Federation

Matveev Alexander V. – Candidate of Medical Sciences, Associate Professor of the Department of Clinical Pharmacology and Therapy. SPIN code: 8518-1320

Moscow



K. B. Mirzaev
Russian Medical Academy of Continuing Professional Education of the Ministry of Health of Russia
Russian Federation

Mirzaev Karin B. – Candidate of Medical Sciences, Associate Professor of the Department of Clinical Pharmacology and Therapy. SPIN code: 8308-7599

Moscow



D. A. Sychev
Russian Medical Academy of Continuing Professional Education of the Ministry of Health of Russia
Russian Federation

Sychev Dmitry A. – Doctor of Medical Sciences, Professor, Corresponding Member RAS, Rector, Head. Department of Clinical Pharmacology and Therapy. SPIN code: 4525-7556

Moscow



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Supplementary files

1. Пояснения к «Мониторингу безопасности применения фавипиравира: управление рисками развития нежелательных лекарственных реакций в клинической практике»
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Type Исследовательские инструменты
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Kiselev Yu.Yu., Matveev A.V., Mirzaev K.B., Sychev D.A. Monitoring of safety using favipiravir: risk management of adverse drug reactions in clinical practice. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2020;(4S):115-119. (In Russ.) https://doi.org/10.37489/2588-0519-2020-S4-115-119

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ISSN 2588-0519 (Print)
ISSN 2618-8473 (Online)