Drug Safety for Children — International Monitoring Data for 50 Years
B. K. Romanov,
Yu. V. Olefir,
R. N. Alyautdin,
S. V. Glagolev,
V. A. Polivanov,
L. I. Ilienko,
S. P. Alpatov,
N. V. Bogush,
N. M. Buyanova,
I. V. Ganshina,
G. O. Dibirova,
N. B. Dmitrieva,
I. B. Zhukova,
E. V. Kalinina,
A. V. Kirillova,
N. M. Kiseleva,
G. V. Kukushkin,
T. I. Leonteva,
M. L. Maximov,
E. V. Markina,
S. E. Mileshina,
D. E. Yurov https://doi.org/10.30895/2312-7821-2019-7-2-57-64
Abstract
The review article presents a summary of adverse drug reactions (ADR) in children, information about which was received in 1968–2018 in the International database VigiBase (Uppsala monitoring center, UMC). Of the 18.4 million Individual Safety Case Reports (ICSR) received over 50 years by VigiBase, 1.47 million ICSR contain information on the safety of pharmacotherapy in patients under the age of 18, including: 34 510 reports contain information on ADR in children under the age of 27 days, 415 678 — in children aged 28 days to 23 months, 613 676 — aged 2 to 11 years and 405 202 ICSR — in patients aged 12 to 17 years inclusive. During 2018 141 655 ICSR ADR of children in VigiBase was received. The most common reason for submitting reports on adverse effects in children was vaccines, antibiotics, non-steroidal antiinflammatory drugs, analgesics-antipyretics, anti-acne and valproic acid. The most common side effects of drugs in children were the following ADR: hyperthermia, rash, vomiting, nausea, urticaria, diarrhea, itching, headache, erythema at injection site, convulsion. Separate data on 6 age groups about 10 most frequent ADR in children and about 10 medicines which ICSR most often arrived in VigiBase for 50 years and for 2018 are given.
Funding: The study reported in this publication was carried out as part of a publicly funded research project No. 056-00154-19-00 and was supported by the Scientific Centre for Expert Evaluation of Medicinal Products (R&D public accounting No. AAAA-A18-118021590048-3)
About the Authors
B. K. Romanov
Scientific Centre for Expert Evaluation of Medicinal Products;Pirogov Russian National Research Medical University
Russian Federation
Russian Federation
Boris K. Romanov, Doctor of Medical Sciences, Associate Professor
Yu. V. Olefir
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
Yuri V. Olefir, Doctor of Medical Sciences, Senior Research Associate
R. N. Alyautdin
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
Renad N. Alyautdin, Doctor of Medical Sciences, Full Professor
S. V. Glagolev
Federal Service for Surveillance in Healthcare (Roszdravnadzor)
Russian Federation
Russian Federation
Sergey V. Glagolev, Candidate of Medical Sciences
Scopus Author ID: https://www.scopus.com/authid/detail.uri?authorId=57193931109
V. A. Polivanov
Federal State Budgetary Institution «Information and Methodological Centre for Expert Evaluation,
Recording and Analysis of Circulation of Medicinal Products» of Roszdravnadzor
Russian Federation
Russian Federation
Vitaly A. Polivanov
Scopus Author ID: https://www.scopus.com/authid/detail.uri?authorId=57193928059
L. I. Ilienko
Pirogov Russian National Research Medical University
Russian Federation
Russian Federation
Lidia I. Ilienko, Doctor of Medical Sciences, Full Professor, Honored Doctor of the Russian Federation
Scopus Author ID: https://www.scopus.com/authid/detail.uri?authorId=6603344611
S. P. Alpatov
Pirogov Russian National Research Medical University
Russian Federation
Russian Federation
Sergey P. Alpatov, Candidate of Medical Sciences
N. V. Bogush
Pirogov Russian National Research Medical University
Russian Federation
Nadezhda V. Bogush
Russian Federation
Nadezhda V. Bogush
N. M. Buyanova
Pirogov Russian National Research Medical University
Russian Federation
Russian Federation
Natalia M. Buyanova
I. V. Ganshina
Pirogov Russian National Research Medical University
Russian Federation
Russian Federation
Irina V. Ganshina
G. O. Dibirova
Pirogov Russian National Research Medical University
Russian Federation
Russian Federation
Gulnara O. Dibirova, Candidate of Medical Sciences, Associate Professor
N. B. Dmitrieva
Pirogov Russian National Research Medical University
Russian Federation
Russian Federation
Natalia B. Dmitrieva, Candidate of Medical Sciences, Associate Professor
Scopus Author ID: https://www.scopus.com/authid/detail.uri?authorId=7101760859
I. B. Zhukova
Pirogov Russian National Research Medical University
Russian Federation
Russian Federation
Inna B. Zhukova, Candidate of Medical Sciences, Associate Professor
Scopus Author ID: https://www.scopus.com/authid/detail.uri?authorId=7004431009
E. V. Kalinina
Pirogov Russian National Research Medical University
Russian Federation
Russian Federation
Elena V. Kalinina, Candidate of Medical Sciences
Scopus Author ID: https://www.scopus.com/authid/detail.uri?authorId=8958305800
A. V. Kirillova
Pirogov Russian National Research Medical University
Russian Federation
Russian Federation
Anna V. Kirillova, Candidate of Medical Sciences
N. M. Kiseleva
Pirogov Russian National Research Medical University
Russian Federation
Russian Federation
Nina M. Kiseleva, Doctor of Biological Sciences, Full Professor
G. V. Kukushkin
Pirogov Russian National Research Medical University
Russian Federation
Russian Federation
German V. Kukushkin, Candidate of Medical Sciences, Associate Professor
T. I. Leonteva
Pirogov Russian National Research Medical University
Russian Federation
Russian Federation
Tatiana I. Leonteva, Candidate of Biological Sciences
M. L. Maximov
Pirogov Russian National Research Medical University
Kazan State Medical Academy — Branch Campus of the Russian Medical Academy of Continuous Professional Education
Russian Federation
Russian Federation
Maxim L. Maximov, Doctor of Medical Sciences, Associate Professor
E. V. Markina
Pirogov Russian National Research Medical University
Russian Federation
Russian Federation
Elena V. Markina
S. E. Mileshina
Pirogov Russian National Research Medical University
Russian Federation
Russian Federation
Svetlana E. Mileshina, Candidate of Medical Sciences
D. E. Yurov
Pirogov Russian National Research Medical University
Russian Federation
Russian Federation
Dmitry E. Yurov, Candidate of Medical Sciences
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Review
For citations:
Romanov B.K., Olefir Yu.V., Alyautdin R.N., Glagolev S.V., Polivanov V.A., Ilienko L.I., Alpatov S.P., Bogush N.V., Buyanova N.M., Ganshina I.V., Dibirova G.O., Dmitrieva N.B., Zhukova I.B., Kalinina E.V., Kirillova A.V., Kiseleva N.M., Kukushkin G.V., Leonteva T.I., Maximov M.L., Markina E.V., Mileshina S.E., Yurov D.E. Drug Safety for Children — International Monitoring Data for 50 Years. Safety and Risk of Pharmacotherapy. 2019;7(2):57-64. (In Russ.) https://doi.org/10.30895/2312-7821-2019-7-2-57-64
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