Comparative assessment of tolerability and risk of pharmacotherapy with botulinum toxin type a drugs in children with cerebral palsy with severe spasticity syndrome

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.

Keywords

preparations of botulinum toxin type A / treatment of spasticity syndrome / cerebral palsy / reporting of adverse drug reactions / efficacy / safety

References

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