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

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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 127051

Dmitry 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 127051

Natalia 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, 125993

Anna 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

  1. Zmanovskaya V.A., Levitina E.V., Popkov D.A., Butorina M.N., Pavlova O.L. Long-term use of botulinum toxin type A: Dysport® in the comprehensive rehabilitation of children with spastic forms of paralysis. Zhurnal nevrologii i psikhiatii im. S. S. Korsakova. 2014; 114(7): 33-6. (in Russian)
  2. Cote T.R., Mohan A.K., Polder J.A., Walton M.K., Braun M.M. Botulinum toxin type A injections: adverse events reported to the US Food and Drug Administration in therapeutic and cosmetic cases. J Am Acad Dermatol. 2005; 53(3): 407-15. doi: 10.1016/j.jaad.2005.06.011.
  3. Howell K., Selber P., Graham H.K., Reddihough D. Botulinum neurotoxin A: an unusual systemic effect. J Paediatr Child Health. 2007; 43(6): 499-501. doi: 10.1111/j.1440-1754.2007.01122.x.
  4. Kuehn B.M. FDA requires black box warnings on labeling for botulinum toxin products. JAMA. 2009; 301(22): 2316. doi: 10.1001/jama.2009.780.
  5. Montastruc J., Marque P., Moulis F., Bourg V., Lambert V., Durrieu G. et al. Adverse drug reactions of botulinum neurotoxin type A in children with cerebral palsy: a pharmaco-epidemiological study in VigiBase. Dev Med Child Neurol. 2017; 59 (3): 329-34. doi: 10.1111/dmcn.13286.
  6. O’Flaherty S.J., Janakan V., Morrow A.M., Scheinberg A.M., Waugh M-CA. Adverse events and health status following botulinum toxin type A injections in children with cerebral palsy. Dev Med Child Neurol. 2011; 53(2): 125-30. doi: 10.1111/j.1469-8749.2010.03814.x.
  7. Naidu K., Smith K., Sheedy M., Adair B, Yu X., Graham H.K. Systemic adverse events following botulinum toxin A therapy in children with cerebral palsy. Dev Med Child Neurol. 2010; 52(2): 139-44. doi: 10.1111/j.1469-8749.2009.03583.x.
  8. Romanov B.K., Olefir Yu.V., Alyautdin R.N., Glagolev S.V., Polivanov V.A., Ilienko L.I. et al. The safety of the use of drugs in children – international monitoring data for 50 years. Safety and risk of pharmacotherapy. 2019; 7(2): 57-64. (in Russian) doi: 10.30895/2312-7821-2019-7-2-57-64.
  9. Treatment and Rehabilitation of Children with Spastic Forms of Cerebral Palsy. Methodical recommendations. No. 26. [Lechenie i Reabilitatsiya Detei so Spasticheskimi Formami Tserebral’nogo Paralicha. Metodicheskie rekomendatsii № 26.] Moscow: 2016. (in Russian)
  10. Kurenkov A. L., Bursagova B. I., Kuzenkova L. M., Petrova S.A. Use of botulinum toxin type A in spastic forms of cerebral palsy, effective pharmacotherapy. Effektivnaya farmakoterapiya. 2013; (3): 14-20. (in Russian)

Supplementary files

Supplementary Files
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1. Fig. 1. The number of spontaneous messages (%) when using Botox® depending on the age of the children.

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2. Fig. 2. The number of spontaneous messages (%) when using Xeomin® depending on the age of the children.

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3. Fig. 3. The number of spontaneous messages (%) when using the drug Dysport®, depending on the age of the children.

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