clinvestКачественная клиническая практикаKachestvennaya Klinicheskaya Praktika = Good Clinical Practice2588-05192618-8473ООО «Издательство ОКИ10.37489/2588-0519-2020-S4-115-119clinvest-541Research ArticleАКТУАЛЬНЫЕ ОБЗОРЫACTUAL REVIEWМониторинг безопасности применения фавипиравира: управление рисками развития нежелательных лекарственных реакций в клинической практикеMonitoring of safety using favipiravir: risk management of adverse drug reactions in clinical practicehttps://orcid.org/0000-0002-6753-8572КиселёвЮ. Ю.KiselevYu. Yu.

Киселёв Юрий Юрьевич – PhD, доцент факультета наук о здоровье OsloMet

Осло

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

Oslo

https://orcid.org/0000-0002-6636-3950МатвеевА. В.MatveevA. V.

Матвеев Александр Витальевич – к. м. н., доцент кафедры клинической фармакологии и терапии. SPIN-код: 8518-1320

Москва

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

Moscow

https://orcid.org/0000-0002-9307-4994МирзаевК. Б.MirzaevK. B.

Мирзаев Карин Бадавиевич – к. м. н., доцент кафедры клинической фармакологии и терапии. SPIN-код: 8308-7599

Москва

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

Moscow

https://orcid.org/0000-0002-4496-3680СычёвД. А.SychevD. A.

Сычёв Дмитрий Алексеевич – д. м. н., профессор, член-корр. РАН, ректор, зав. кафедрой клинической фармакологии и терапии. SPIN-код: 4525-7556

Москва

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

Moscow

dmitriy.alex.sychev@gmail.comУниверситет Осло МетрополитенНорвегияOslo Metropolitan UniversityNorwayФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава РоссииРоссияRussian Medical Academy of Continuing Professional Education of the Ministry of Health of RussiaRussian Federation20202810202004SФармаCOVID115119Copyright © Киселёв Ю.Ю., Матвеев А.В., Мирзаев К.Б., Сычёв Д.А., 20202020Киселёв Ю.Ю., Матвеев А.В., Мирзаев К.Б., Сычёв Д.А.Kiselev Y.Y., Matveev A.V., Mirzaev K.B., Sychev D.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.clinvest.ru/jour/article/view/541

Мировой опыт клинического применения фавипиравира весьма ограничен. Его безопасность требует дальнейшего изучения. Принципиально значимо предупреждение тератогенных эффектов (обязательное проведение теста на беременность до начала терапии, соблюдение эффективной контрацепции и женщинами, и мужчинами), контроль уровня мочевой кислоты, трансаминаз и ЭКГ. Необходима настороженность в отношении новых, недостаточно документированных или ранее не зарегистрированных нежелательных эффектов, например, моторных нарушений и падений. Пациенты должны быть в полной мере проинформированы о всех рисках терапии до её начала. Особого внимания требует своевременное заполнение утверждённых форм извещений о развитии НР и репортирование в сроки, согласно Приказа Федеральной службы по надзору в сфере здравоохранения от 15 февраля 2017 г. № 1071 «Об утверждении Порядка осуществления фармаконадзора».

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.»

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The authors declare that there are no conflicts of interest present.