Безопасность и риск фармакотерапии (Jun 2019)

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

DOI
https://doi.org/10.30895/2312-7821-2019-7-2-57-64
Journal volume & issue
Vol. 7, no. 2
pp. 57 – 64

Abstract

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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.

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