Hepatotoxicity of new oral anticoagulants: literature review
https://doi.org/10.24411/2588- 0519-2018-10052
Abstract
Tis article presents a literature review of hepatotoxicity of new oral anticoagulants which was obtained by different methods options of pharmacovigilance. Te overview includes 35 information sources 24 articles, 4 methodic or regulatory guidelines, 3 expert group publications, 3 new drug application overviews and 1 source being clinical trial register search results. Upon the results of the literature review, it was concluded that pharmacovigilance methods analyzing data obtained within real world medical practice give more opportunities for safety signal management comparing to those analyzing only data obtained within randomized clinical trials.
About the Authors
N. S. Popova
FSBEI HE I.P. Pavlov SPbSMU MOH Russia
Russian Federation
Russian Federation
Popova Natalya
Saint-Petersburg
SPIN-code: 3592-9814
A. V. Philippova
FSBEI HE I.P. Pavlov SPbSMU MOH Russia
Russian Federation
Russian Federation
Filippova Anastasia, Post-graduate student, Department of Clinical Pharmacology and Evidence-Based Medicine, First St. Petersburg State Medical University named afer I.P. Pavlova
Saint-Petersburg
SPIN-code: 3989-9803
T. L. Gakankin
FSBEI HE I.P. Pavlov SPbSMU MOH Russia
Russian Federation
Russian Federation
Gakankin Timofey, Candidate of Medical Sciences, Head of the laboratory of pharmacoepidemiology and pharmacokinetics in the First St. Petersburg State Medical University named afer acad. I.P. Pavlov of the Ministry of Health of the Russian Federation
Saint-Petersburg
SPIN-code: 7808-0586
A. S. Kolbin
FSBEI HE I.P. Pavlov SPbSMU MOH Russia;
Federal State Budgetary Educational Institution of Higher Education «Saint-Petersburg State University»
Russian Federation
Russian Federation
Kolbin Alexey, MD, Professor, Head of the Department of Clinical Pharmacology and Evidence-Based Medicine, FSBEI HE I.P. Pavlov SPbSMU MOH Russia; professor of the Department of Pharmacology, Medical Faculty, St. Petersburg State University
Saint-Petersburg
SPIN-code: 7966-0845
A. R. Kasimova
FSBEI HE I.P. Pavlov SPbSMU MOH Russia;
Russian research Institute of traumatology and orthopedics named afer R. R. Vreden
Russian Federation
Russian Federation
Kasimova Alina
Saint-Petersburg
SPIN-code: 3131-4385
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Review
For citations:
Popova N.S., Philippova A.V., Gakankin T.L., Kolbin A.S., Kasimova A.R. Hepatotoxicity of new oral anticoagulants: literature review. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2018;(3):66-72. (In Russ.) https://doi.org/10.24411/2588- 0519-2018-10052
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