Email this article Comparative assessment of tolerability and risk of pharmacotherapy with botulinum toxin type a drugs in children with cerebral palsy with severe spasticity syndrome
- Authors: Arkhipov V.V.1, Goryachev D.V.2, Chebanenko N.V.3, Solovyova A.P.2
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Affiliations:
- Federal State Budgetary Institution “Scientific Center for Examination of Medical Devices” of the Ministry of Health of the Russian Federation
- Federal State Budgetary Institution "Scientific Center for Expert Evaluation of Medical Use Products" of the Ministry of Health of the Russian
- Federal State Budgetary Educational Institution of Further Professional Education "Russian Medical Academy of Continuous Professional Education" of the Ministry of Healthcare of the Russian Federation
- Issue: Vol 26, No 1 (2020)
- Pages: 33-40
- Section: Clinical pharmacology and pharmaceuticals
- URL: https://medjrf.com/0869-2106/article/view/25838
- DOI: https://doi.org/10.18821/0869-2106-2020-26-1-33-40
- ID: 25838
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Abstract
This paper presents a comprehensive assessment of safety monitoring of the use of botulinum toxin type A (BTA) drugs in the WHO databases (VigiBase) and automated information system (AIS) “Roszdravnadzor-Pharmacovigilance”, as well as a comparison of the dynamics of receipt of messages.
The authors present a post-marketing study of domestic experience in the use of BTA drugs (Dysport, Botox, and Xeomin) based on a retrospective clinical and pharmacological analysis of 169 medical records of children with cerebral palsy in whom these drugs were used to treat spasticity syndrome.
Analysis of the spectrum of adverse events, which were mentioned in 10 (5.9%) medical records, showed that their nature corresponded to the data set out in the instructions for medical use. Serious adverse reactions according to the criteria of severity “death” and “threat to life”, with a high degree of reliability of cause-and-effect relationship were not revealed during the study, which confirms a sufficiently high safety profile of these drugs.
This paper focuses on improving the methodology for assessing the effectiveness and safety of BTA drugs for the treatment of spasticity syndrome in children and the need to identify and report all adverse drug reactions.
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About the authors
Vladimir V. Arkhipov
Federal State Budgetary Institution “Scientific Center for Examination of Medical Devices” of the Ministry of Health of the Russian Federation
Author for correspondence.
Email: arkhipov2005@rambler.ru
ORCID iD: 0000-0002-1441-3418
MD, PhD, DSc
Russian Federation, 8/2 Petrovsky Blvd, Moscow 127051Dmitry V. Goryachev
Federal State Budgetary Institution "Scientific Center for Expert Evaluation of Medical Use Products" of the Ministry of Health of the Russian
Email: Gorachev@expmed.ru
ORCID iD: 0000-0001-8583-2372
MD, PhD, DSc
Russian Federation, 8/2 Petrovsky Blvd, Moscow 127051Natalia V. Chebanenko
Federal State Budgetary Educational Institution of Further Professional Education "Russian Medical Academy of Continuous Professional Education" of the Ministry of Healthcare of the Russian Federation
Email: nataqwe@yndex.ru
ORCID iD: 0000-0002-7231-0249
MD, PhD, associate Professor of the Department of children's neurology
Russian Federation, 2/1, Barrikadnayast., Moscow, 125993Anna P. Solovyova
Federal State Budgetary Institution "Scientific Center for Expert Evaluation of Medical Use Products" of the Ministry of Health of the Russian
Email: Soloviova@expmed.ru
ORCID iD: 0000-0001-9244-8934
Russian Federation, 8/2 Petrovsky Blvd, Moscow 127051
References
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