PM&R
Volume 2, Issue 4 , Pages 282-284 , April 2010

Safety Considerations in the Use of Botulinum Toxins in Children With Cerebral Palsy

  • Susan D. Apkon, MD

      Affiliations

    • Department of Rehabilitation Medicine, University of Washington; and Department of Rehabilitation Medicine, Seattle Children's, M/S W-9847, PO Box 5371, Seattle, WA⁎
    • Corresponding Author InformationAddress correspondence to S.D.A.
    • ,
  • Danielle Cassidy, PharmD

      Affiliations

    • Investigational Drug Services & Anticoagulation Clinical Pharmacist, The Children's Hospital, Denver, CO†

Received 22 December 2009 ,Accepted 17 February 2010.

References 

  1. Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B). http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm070366.htm2008;Accessed February 23, 2010
  2. Dolly JO. Therapeutic and research exploitation of botulinum neurotoxins. Eur J Neurol. 1997;4:S5–S10
  3. Yablon SA, Brashear A, Gordon MF, et al. Formation of neutralizing antibodies in patients receiving botulinum toxin type A for treatment of poststroke spasticity: A pooled-data analysis of three clinical trials. Clin Ther. 2007;29:683–690
  4. Product Information: BOTOX (onobotulinumtoxinA). Irvine, CA: Allergan Pharmaceuticals; 2009;
  5. Delgado MR, Hirtz D, Aisen M, et al. Practice parameter: Pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review): Report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology;74:336-343.
  6. Ade-Hall RA, Moore AP. Botulinum toxin type A in the treatment of lower limb spasticity in cerebral palsy. Cochrane Database Syst Rev. 2000;CD001408
  7. Bjornson K, Hays R, Graubert C, et al. Botulinum toxin for spasticity in children with cerebral palsy: A comprehensive evaluation. Pediatrics. 2007;120:49–58
  8. Criswell SR, Crowner BE, Racette BA. The use of botulinum toxin therapy for lower-extremity spasticity in children with cerebral palsy. Neurosurg Focus. 2006;21:e1
  9. Koman LA, Mooney JF, Smith BP, Walker F, Leon JM. Botulinum toxin type A neuromuscular blockade in the treatment of lower extremity spasticity in cerebral palsy: A randomized, double-blind, placebo-controlled trial (BOTOX Study Group). J Pediatr Orthop. 2000;20:108–115
  10. Lukban MB, Rosales RL, Dressler D. Effectiveness of botulinum toxin A for upper and lower limb spasticity in children with cerebral palsy: A summary of evidence. J Neural Transm. 2009;116:319–331
  11. Sutherland DH, Kaufman KR, Wyatt MP, Chambers HG, Mubarak SJ. Double-blind study of botulinum A toxin injections into the gastrocnemius muscle in patients with cerebral palsy. Gait Posture. 1999;10:1–9
  12. Wasiak J, Hoare B, Wallen M. Botulinum toxin A as an adjunct to treatment in the management of the upper limb in children with spastic cerebral palsy. Cochrane Database Syst Rev. 2004;CD003469
  13. Graham HK, Aoki KR, Autti-Ramo I, et al. Recommendations for the use of botulinum toxin type A in the management of cerebral palsy. Gait Posture. 2000;11:67–79
  14. Kinnett D. Botulinum toxin A injections in children: Technique and dosing issues. Am J Phys Med Rehabil. 2004;83:S59–S64
  15. Public Citizen. Petition to the FDA requesting regulatory action concerning the possible spread of botulinum toxin (Botox, Myobloc) from the site of injection to other parts of the body (HRG Publication #1834). http://www.citizen.org/publications/release.cfm?ID=75592008;Accessed February 23, 2010
  16. Albavera-Hernandez C, Rodriguez JM, Idrovo AJ. Safety of botulinum toxin type A among children with spasticity secondary to cerebral palsy: a systematic review of randomized clinical trials. Clin Rehabil. 2009;23:394–407
  17. Crowner BE, Racette BA. Prospective study examining remote effects of botulinum toxin a in children with cerebral palsy. Pediatr Neurol. 2008;39:253–258
  18. Willis AW, Crowner B, Brunstrom JE, Kissel A, Racette BA. High dose botulinum toxin A for the treatment of lower extremity hypertonicity in children with cerebral palsy. Dev Med Child Neurol. 2007;49:818–822
  19. Crowner BE, Brunstrom JE, Racette BA. Iatrogenic botulism due to therapeutic botulinum toxin a injection in a pediatric patient. Clin Neuropharmacol. 2007;30:310–313
  20. Howell K, Selber P, Graham HK, Reddihough D. Botulinum neurotoxin A: An unusual systemic effect. J Paediatr Child Health. 2007;43:499–501
  21. Partikian A, Mitchell WG. Iatrogenic botulism in a child with spastic quadriparesis. J Child Neurol. 2007;22:1235–1237
  22. Kolaski K, Ajizian SJ, Passmore L, Pasutharnchat N, Koman LA, Smith BP. Safety profile of multilevel chemical denervation procedures using phenol or botulinum toxin or both in a pediatric population. Am J Phys Med Rehabil. 2008;87:556–566
  23. Food and Drug Administration. Follow-up to the February 8, 2008, Early Communication about an Ongoing Safety Review of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) (FDA response to petition). http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm143819.htm2009;
  24. Bazzano AT, Mangione-Smith R, Schonlau M, Suttorp MJ, Brook RH. Off-label prescribing to children in the United States outpatient setting. Acad Pediatr. 2009;9:81–88

PII: S1934-1482(10)00131-0

doi: 10.1016/j.pmrj.2010.02.006

PM&R
Volume 2, Issue 4 , Pages 282-284 , April 2010

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