Journal of the American Academy of Dermatology
Volume 53, Issue 3 , Pages 407-415 , September 2005

Botulinum toxin type A injections: Adverse events reported to the US Food and Drug Administration in therapeutic and cosmetic cases

  • Timothy R. Coté, MD, MPH

      Affiliations

    • From the Food and Drug Administration, Center for Biologics Evaluation and Research
    • ,
  • Aparna K. Mohan, MD, PhD

      Affiliations

    • From the Food and Drug Administration, Center for Biologics Evaluation and Research
    • ,
  • Jacquelyn A. Polder, BSN, MPH

      Affiliations

    • From the Food and Drug Administration, Center for Biologics Evaluation and Research
    • ,
  • Marc K. Walton, MD, PhD

      Affiliations

    • Center for Drug Evaluation and Research
    • ,
  • M. Miles Braun, MD, MPH

      Affiliations

    • From the Food and Drug Administration, Center for Biologics Evaluation and Research
    • Corresponding Author InformationReprint requests: M. Miles Braun, MD, MPH, Food and Drug Administration, Center for Biologics Evaluation and Research, OBE 1401 Rockville Pike, HFM-220 Rockville, MD 20852.

,Accepted 5 June 2005.

References 

  1. Erbguth F. Botulinum toxin, a historical note. Lancet. 1998;351:1280
  2. Scott AB, Rosenbaum A, Collins CC. Pharmacologic weakening of extraocular muscles. Invest Ophthalmol Vis Sci. 1973;12:924–927
  3. Scott AB, Suzuki D. Systemic toxicity of botulinum toxin by intramuscular injection in the monkey. Mov Disord. 1988;3:333–335
  4. Scott AB. Botulinum toxin injection of eye muscles to correct strabismus. Trans Am Ophthalmol Soc. 1981;79:734–770
  5. PDR [package insert] (Allergan Botox). Available at: http://www.botox.com/site/professionals/prescribing_info/botox.asp. Accessed December 17, 2004
  6. PDR [package insert] (Allergan Botox Cosmetic). Available at: http://www.botox.com/site/professionals/prescribing_info/botox_cosmetic.asp. Accessed December 17, 2004.
  7. Verheyden J, Blitzer A. Other non-cosmetic uses of Botox. Dis Mon. 2002;48:357–366
  8. O'Brien CF. Treatment of spasticity with botulinum toxin. Clin J Pain. 2002;18(Suppl):S182–S190
  9. Gracies J, Elovic E, McGuire JR, Simpson DM. Traditional pharmacologic treatments for spasticity. Part I: local treatments. In Spasticity: etiology, evaluation, management and the role of botulinum toxin. Muscle Nerve Suppl. 1997;6:S61–S91
  10. Flett PJ. Rehabilitation of spasticity and related problems in childhood cerebral palsy. J Paediatr Child Health. 2003;39:6–14
  11. Koman LA, Paterson Smith B, Balkrishnan R. Spasticity associated with cerebral palsy in children: guidelines for the use of botulinum A toxin. Paediatr Drugs. 2003;5:11–23
  12. Bang MS, Chung SG, Kim SB, Kim SJ. Change of dynamic gastrocnemius and soleus muscle length after block of spastic calf muscle in cerebral palsy. Am J Phys Med Rehabil. 2002;81:760–764
  13. Yang TF, Fu CP, Kao NT, Chan RC, Chen SJ. Effect of botulinum toxin type A on cerebral palsy with upper limb spasticity. Am J Phys Med Rehabil. 2003;82:284–289
  14. Polak F, Morton R, Ward C, Wallace WA, Doderlein L, Siebel A. Double-blind comparison study of two doses of botulinum toxin A injected into calf muscles in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2002;44:551–555
  15. Dursun N, Dursun E, Alican D. The role of botulinum toxin A in the management of lower limb spasticity in patients with cerebral palsy. Int J Clin Pract. 2002;56:564–567
  16. Berweck S, Feldkamp A, Francke A, Nehles J, Schwerin A, Heinen F. Sonography-guided injection of botulinum toxin A in children with cerebral palsy. Neuropediatrics. 2002;33:221–223
  17. Brashear A, Gordon MF, Kassicieh VD, Marciniak C, Do M, Lee CH, et al. Botox Post-Stroke Spasticitiy Study Group. Intramuscular injections of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N Engl J Med. 2002;347:395–400
  18. Yelnik AP, Colle FM, Bonan IV, Lamotte DR. Disabling overactivity of the extensor hallicus longus after stroke: clinical expression and efficacy of botulinum toxin type A. Arch Phys Med Rehabil. 2003;84:147–149
  19. Childers MK, Wilson DJ, Gnatz SM, Conway RR, Sherman AK. Botulinum toxin type A use in piriformis muscle syndrome: a pilot study. Am J Phys Med Rehabil. 2002;81:751–759
  20. Fishman LM, Anderson C, Rosner B. Botox and physical therapy in the treatment of piriformis syndrome. Am J Phys Med Rehabil. 2002;81:936–942
  21. Loder E, Biondi D. Use of botulinum toxins for chronic headaches: a focused review. Clin J Pain. 2002;18(Suppl):S169–S176
  22. Freund BJ, Schwartz M. Relief of tension-type headache symptoms in subjects with temporomandibular disorders treated with botulinum toxin-A. Headache. 2002;42:1033–1037
  23. Rahmann Evers S, Vollmer-Haase J, Husstedt IW. Treatment of headache with botulinum toxin A—a review according to evidence-based medicine criteria. Cephalalgia. 2002;22:699–710
  24. Singer HS. The treatment of tics. Curr Neurol Neurosci Rep. 2001;1:195–202
  25. Sapienza CM, Cannito MP, Murry T, Branski R, Woodson G. Acoustic variations in reading produced by speakers with spasmodic dysphonia pre-Botox injection and within early stages of post-Botox injection. J Speech Lang Hear Res. 2002;45:830–843
  26. Argoff CE. A focused review on the use of botulinum toxins for neuropathic pain. Clin J Pain. 2002;18(Suppl):S177–S181
  27. Heckmann M, Heyer G, Brunner B, Plewig G. Botulinum toxin type A injection in the treatment of lichen simplex: an open pilot study. J Am Acad Dermatol. 2002;47:617–619
  28. Glogau RG. Review of the use of botulinum toxin for hyperhidrosis and cosmetic purposes. Clin J Pain. 2002;18(Suppl):S191–S197
  29. Campanati A, Penna L, Guzzo T, Menotta L, Silvestri B, Lagalla G, et al. Quality-of-life assessment in patients with hyperhidrosis before and after treatment with botulinum toxin: results of an open-label study. Clin Ther. 2003;25:298–308
  30. Sevim S, Sogu O, Kaleagasi H. Botulinum toxin-A therapy for palmar and plantar hyperhidrosis. Acta Neurol Belg. 2002;102:167–170
  31. Konrad H, Karamfilov T, Wollina U. Intracutaneous botulinum toxin A versus ablative therapy of Hailey-Hailey disease—a case report. J Cosmet Laser Ther. 2001;3:181–184
  32. Wollina U, Karamfilov T. Adjuvant botulinum toxin A in dyshidrotic hand eczema: a controlled prospective pilot study with left-right comparison. J Eur Acad Dermatol Venereol. 2002;16:40–42
  33. Neubrand M, Scheurlen C, Schepke M, Sauerbruch T. Long-term results and prognostic factors in the treatment of achalasia with botulinum toxin. Endoscopy. 2002;34:519–523
  34. Brant C, Moraes-Filho JP, Siqueira E, Nasi A, Libera E, Morais M, et al. Intrasphincteric botulinum toxin injection in the treatment of chagasic achalasia. Dis Esophagus. 2003;16:33–38
  35. Bansal R, Nostrant TT, Scheiman JM, Koshy S, Barnett JL, Elta GH, et al. Intrasphincteric botulinum toxin verses pneumatic balloon dilation for treatment of primary achalasia. J Clin Gastroenterol. 2003;36:209–214
  36. Mitka M. Colon and rectal surgeons are trying Botox treatment, too. JAMA. 2002;288:439–440
  37. Mentes BB, Irkorucu O, Akin M, Leventoglu S, Tatlicioglu E. Comparison of botulinum toxin injection and lateral internal sphincterotomy for the treatment of chronic anal fissure. Dis Colon Rectum. 2003;46:232–237
  38. Madalinski MH, Slawek J, Duzynski W, Zbytek B, Jagiello K, Adrich Z, et al. Side effects of botulinum toxin injection for benign anal disorders. Eur J Gastroenterol Hepatol. 2002;14:853–856
  39. Brisinda D, Maria G, Fenici R, Civello IM, Brisinda G. Safety of botulinum neurotoxin treatment in patients with chronic anal fissure. Dis Colon Rectum. 2003;46:419–420
  40. Spinelli P, Gallardini G. Botulinum toxin type A (Dysport) for the treatment of Zenker's diverticulum. Surg Endosc. 2003;17:660
  41. Tugnoli V, Marchese Ragona R, Eleopra R, Quatrale R, Capone JG, Pastore A, et al. The role of gustatory flushing in Frey's syndrome and its treatment with botulinum toxin type A. Clin Auton Res. 2002;12:174–178
  42. Clark M, Koppel DA. Botulinum toxin in the treatment of Frey's syndrome. [letter] Br J Oral Maxillofac Surg. 2001;39:483
  43. Ellies M, Rohrbach-Volland S, Arglebe C, Wilken B, Laskawi R, Hanefeld F. Successful management of drooling with botulinum toxin A in neurologically disabled children. Neuropediatrics. 2002;33:327–330
  44. Friedman A, Potulska A. Botulinum toxin for treatment of parkinsonian sialorrhea. Neurol Neurochir Pol. 2001;35(Suppl):23–27
  45. von Lindern JJ, Niederhagen B, Appel T, Berge S, Reich RH. New prospects in the treatment of traumatic and postoperative parotid fistulas with type A botulinum toxin. Plast Reconstr Surg. 2002;109:2443–2445
  46. Smith CP, O'Leary M, Erickson J, Somogyi GT, Chancellor MB. Botulinum toxin uretheral sphincter injection resolves urinary retention after pubovaginal sling operation. Int Urogynecol J Pelvic Floor Dysfunct. 2002;13:55–56
  47. Schulte-Baukloh H, Michael T, Schobert J, Stolze T, Knispel HH. Efficacy of botulinum-A toxin in children with detrusor hyperreflexia due to myelomeningocele: preliminary results. Urology. 2002;59:325–328
  48. Montoya FJ, Riddell CE, Eaesar R, Hauge S. Treatment of gustatory hyperlacrimation (crocodile tears) with injection of botulinum toxin into the lacrimal gland. Eye. 2002;16:705–709
  49. Schwartz M, Freund B. Treatment of temporomandibular disorders with botulinum toxin. Clin J Pain. 2002;18(Suppl):S198–S203
  50. Rollnik JD, Meier PN, Manns MP, Goke M. Antral injections of botulinum A toxin for the treatment of obesity. Ann Intern Med. 2003;138:359–360
  51. Difazio M, Jabbari B. A focused review of the use of botulinum toxins for low back pain. Clin J Pain. 2002;18(Suppl):S155–S162
  52. Kocs D, Fendrick AM. Effect of off-label use of oncology drugs on pharmaceutical costs: the rituximab experience. Am J Manag Care. 2003;9:393–402
  53. Stone KJ, Viera AJ, Parman CL. Off-label applications for SSRIs. Am Fam Physician. 2003;68:425–427
  54. Off-label use of tumor necrosis factor inhibitors on ankylosing spondylitis, ulcerative colitis, and psoriasis. TEC Bull. 2003;20:9–18
  55. American Society of Plastic Surgeons. Available at http://www.plasticsurgery.org/public_education/procedures/Botox.cfm. Accessed December 17, 2004.
  56. American Society for Dermatologic Surgery. Available at http://www.asds-net.org/Patients/patients-procedures.html. Accessed December 17, 2004.
  57. American Society of Aesthetic Plastic Surgery. Available at http://www.surgery.org/public/procedures-botoxing.php. Accessed December 17, 2004.
  58. Gershon SK, Wise RP, Braun MM. Adverse events reported with cosmetic use of botulinum toxin A. Pharmacoepidemiology Drug Safety. 2001;10(Suppl):S135–S136
  59. Brewer T, Colditz GA. Postmarketing surveillance and adverse drug reactions: current perspectives and future needs. JAMA. 1999;281:824–829
  60. Kennedy D, Goldman S, Lillie R. Spontaneous reporting in the United States. In:  Strom BL editors. Pharmacoepidemiology. 3rd ed.. Chicester: Wiley; 2000;p. 151–174
  61. Baum C, Kweder S, Anello C. The spontaneous reporting system in the United States. In:  Strom BL editors. Pharmacoepidemiology. 2nd ed.. New York: John Wiley and Sons; 1994;p. 125–137
  62. Braun MM, Patriarca PA, Ellenberg SS. Syncope after immunization. Arch Pediatr Adolesc Med. 1997;151:255–259

 Dr Coté is currently affiliated with the Centers for Disease Control and Prevention, Atlanta, Ga. Dr Mohan is currently affiliated with Johnson and Johnson, Philadelphia, Pa.Funding source: Food and Drug Administration, in furtherance of its mission of improving patient and consumer safety.Conflicts of interest: None identified.

PII: S0190-9622(05)01985-7

doi: 10.1016/j.jaad.2005.06.011

Journal of the American Academy of Dermatology
Volume 53, Issue 3 , Pages 407-415 , September 2005

Article Tools

* Image Usage & Resolution