{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T09:50:19Z","timestamp":1777888219021,"version":"3.51.4"},"reference-count":63,"publisher":"SAGE Publications","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["PRM"],"published-print":{"date-parts":[[2021,6,25]]},"abstract":"<jats:p>Serious adverse events (serious AEs) following the therapeutic use of Botulinum Toxin Type A (BoNT-A) are infrequent. Children with pediatric spasticity often have comorbidities that can cloud causation around an adverse event (AE). If a serious AE occurs, clear documentation of information sharing and informed consent as well as the provider-patient relationship are critical to minimizing litigation risks. Reviewing the litigation that has occurred following BoNT-A for pediatric spasticity can offer insight into how providers\u2019 perspectives regarding this intervention may differ from those of the public who might serve as jurists. This article offers suggestions for content sharing during the consent process to optimize patient understanding about potential adverse events.<\/jats:p>","DOI":"10.3233\/prm-210031","type":"journal-article","created":{"date-parts":[[2021,5,25]],"date-time":"2021-05-25T12:46:03Z","timestamp":1621946763000},"page":"199-211","source":"Crossref","is-referenced-by-count":0,"title":["Botulinum Toxin Type A injections for pediatric spasticity: Keeping our patients informed and practices safe"],"prefix":"10.1177","volume":"14","author":[{"given":"Edward","family":"Wright","sequence":"first","affiliation":[{"name":"Baylor College of Medicine, Houston, TX, USA"},{"name":"Texas Children\u2019s Hospital, Houston, TX, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lauren","family":"Fetsko","sequence":"additional","affiliation":[{"name":"Baylor College of Medicine, Houston, TX, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","reference":[{"key":"10.3233\/PRM-210031_ref1","doi-asserted-by":"publisher","first-page":"38","DOI":"10.1111\/j.1468-1331.2010.03127.x","article-title":"Botulinum toxin assessment, intervention and follow-up for paediatric upper limb hypertonicity: international consensus statement","volume":"17","author":"Fehlings","year":"2010","journal-title":"Eur J Neurol."},{"key":"10.3233\/PRM-210031_ref2","doi-asserted-by":"publisher","first-page":"9","DOI":"10.1111\/j.1468-1331.2010.03126.x","article-title":"Botulinum toxin assessment, intervention and after-care for lower limb spasticity in children with cerebral palsy: international consensus statement","volume":"17","author":"Love","year":"2010","journal-title":"Eur J Neurol."},{"issue":"5-6","key":"10.3233\/PRM-210031_ref3","doi-asserted-by":"publisher","first-page":"215","DOI":"10.1016\/j.ejpn.2006.08.006","article-title":"European consensus table 2006 on botulinum toxin for children with cerebral palsy","volume":"10","author":"Heinen","year":"2006","journal-title":"Eur J Paediatr Neurol."},{"issue":"1","key":"10.3233\/PRM-210031_ref4","doi-asserted-by":"publisher","first-page":"45","DOI":"10.1016\/j.ejpn.2009.09.005","article-title":"The updated European Consensus 2009 on the use of Botulinum toxin for children with cerebral palsy","volume":"14","author":"Heinen","year":"2010","journal-title":"Eur J Paediatr Neurol."},{"issue":"3","key":"10.3233\/PRM-210031_ref5","doi-asserted-by":"publisher","first-page":"189","DOI":"10.2310\/7010.2006.00041","article-title":"Safety of high-dose botulinum toxin type A therapy for the treatment of pediatric spasticity","volume":"21","author":"Goldstein","year":"2006","journal-title":"J Child Neurol."},{"issue":"6","key":"10.3233\/PRM-210031_ref6","doi-asserted-by":"publisher","first-page":"499","DOI":"10.1111\/j.1440-1754.2007.01122.x","article-title":"Botulinum neurotoxin A: an unusual systemic effect","volume":"43","author":"Howell","year":"2007","journal-title":"J Paediatr Child Health."},{"issue":"5","key":"10.3233\/PRM-210031_ref7","doi-asserted-by":"publisher","first-page":"310","DOI":"10.1097\/WNF.0b013e31804b1a0d","article-title":"Iatrogenic botulism due to therapeutic botulinum toxin A injection in a pediatric patient","volume":"30","author":"Crowner","year":"2007","journal-title":"Clin Neuropharmacol."},{"issue":"11","key":"10.3233\/PRM-210031_ref8","doi-asserted-by":"publisher","first-page":"818","DOI":"10.1111\/j.1469-8749.2007.00818.x","article-title":"High dose botulinum toxin A for the treatment of lower extremity hypertonicity in children with cerebral palsy","volume":"49","author":"Willis","year":"2007","journal-title":"Dev Med Child Neurol."},{"issue":"2","key":"10.3233\/PRM-210031_ref9","doi-asserted-by":"publisher","first-page":"125","DOI":"10.1111\/j.1469-8749.2010.03814.x","article-title":"Adverse events and health status following botulinum toxin type A injections in children with cerebral palsy","volume":"53","author":"O\u2019Flaherty","year":"2011","journal-title":"Dev Med Child Neurol."},{"issue":"7","key":"10.3233\/PRM-210031_ref10","doi-asserted-by":"publisher","first-page":"556","DOI":"10.1097\/PHM.0b013e31817c115b","article-title":"Safety profile of multilevel chemical denervation procedures using phenol or botulinum toxin or both in a pediatric population","volume":"87","author":"Kolaski","year":"2008","journal-title":"Am J Phys Med Rehabil."},{"issue":"2","key":"10.3233\/PRM-210031_ref11","doi-asserted-by":"publisher","first-page":"139","DOI":"10.1111\/j.1469-8749.2009.03583.x","article-title":"Systemic adverse events following botulinum toxin A therapy in children with cerebral palsy","volume":"52","author":"Naidu","year":"2010","journal-title":"Dev Med Child Neurol."},{"issue":"5","key":"10.3233\/PRM-210031_ref12","doi-asserted-by":"publisher","first-page":"895","DOI":"10.1542\/peds.2015-0749","article-title":"Safety of Botulinum Toxin Type A for Children with Nonambulatory Cerebral Palsy","volume":"136","author":"Edwards","year":"2015","journal-title":"Pediatrics."},{"issue":"3","key":"10.3233\/PRM-210031_ref13","doi-asserted-by":"publisher","first-page":"524","DOI":"10.3390\/toxins5030524","article-title":"Safety of botulinum toxin A in children and adolescents with cerebral palsy in a pragmatic setting","volume":"5","author":"Papavasiliou","year":"2013","journal-title":"Toxins (Basel)."},{"issue":"5","key":"10.3233\/PRM-210031_ref14","doi-asserted-by":"publisher","first-page":"498","DOI":"10.1111\/dmcn.13686","article-title":"Severity of cerebral palsy and likelihood of adverse events after botulinum toxin A injections","volume":"60","author":"Swinney","year":"2018","journal-title":"Dev Med Child Neurol."},{"issue":"11","key":"10.3233\/PRM-210031_ref15","doi-asserted-by":"publisher","first-page":"1172","DOI":"10.1111\/dmcn.13995","article-title":"Systemic adverse events after botulinum neurotoxin A injections in children with cerebral palsy","volume":"60","author":"Paget","year":"2018","journal-title":"Dev Med Child Neurol."},{"issue":"4","key":"10.3233\/PRM-210031_ref16","doi-asserted-by":"publisher","first-page":"508","DOI":"10.1017\/s0317167100014049","article-title":"Botulinum toxin-A use in paediatric hypertonia: Canadian practice patterns","volume":"39","author":"Fehlings","year":"2012","journal-title":"Can J Neurol Sci."},{"issue":"11","key":"10.3233\/PRM-210031_ref17","doi-asserted-by":"publisher","first-page":"1059","DOI":"10.1111\/dmcn.12520","article-title":"Recent trends in cerebral palsy survival. Part I: period and cohort effects","volume":"56","author":"Brooks","year":"2014","journal-title":"Dev Med Child Neurol."},{"issue":"3","key":"10.3233\/PRM-210031_ref18","doi-asserted-by":"publisher","first-page":"407","DOI":"10.1016\/j.jaad.2005.06.011","article-title":"Botulinum toxin type A injections: adverse events reported to the US Food and Drug Administration in therapeutic and cosmetic cases","volume":"53","author":"Cot\u00e9","year":"2005","journal-title":"J Am Acad Dermatol."},{"issue":"8","key":"10.3233\/PRM-210031_ref19","doi-asserted-by":"publisher","first-page":"613","DOI":"10.1016\/j.pmrj.2012.04.016","article-title":"Severe nervous system complications after botulinum type A therapy: three case reports with reviews of FDA-reported nervous system adverse effects","volume":"4","author":"Hristova","year":"2012","journal-title":"PM R."},{"key":"10.3233\/PRM-210031_ref20","doi-asserted-by":"publisher","first-page":"79","DOI":"10.1016\/j.tox.2015.07.003","article-title":"Botulinum neurotoxin type A: Actions beyond SNAP-25","volume":"335","author":"Matak","year":"2015","journal-title":"Toxicology."},{"issue":"14","key":"10.3233\/PRM-210031_ref21","doi-asserted-by":"publisher","first-page":"3689","DOI":"10.1523\/JNEUROSCI.0375-08.2008","article-title":"Long-distance retrograde effects of botulinum neurotoxin A","volume":"28","author":"Antonucci","year":"2008","journal-title":"J Neurosci."},{"key":"10.3233\/PRM-210031_ref23","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2009.780"},{"key":"10.3233\/PRM-210031_ref24","unstructured":"FDA Approves BOTOX\u00ae (onabotulinumtoxinA) for Pediatric Patients with Lower Limb Spasticity, Excluding Spasticity Caused by Cerebral Palsy [press release]. Abbvie 2019."},{"key":"10.3233\/PRM-210031_ref25","unstructured":"FDA Approves BOTOX\u00ae (onabotulinumtoxinA) for Pediatric Patients with Upper Limb Spasticity [press release]. Abbvie 2019."},{"key":"10.3233\/PRM-210031_ref26","unstructured":"Ipsen Announces Updated Indication for Dysport\u00ae (abobotulinumtoxinA) for the Treatment of Spasticity in Children [press release]. Ipsen 2020."},{"key":"10.3233\/PRM-210031_ref27","unstructured":"FDA Approves Merz Pharmaceuticals\u2019 Xeomin\u00ae (incobotulinumtoxinA) for the Treatment of Cervical Dystonia and Blepharospasm [press release]. Cision PR Newswire 2010."},{"key":"10.3233\/PRM-210031_ref28","unstructured":"FDA Approves First Pediatric Indication for Xeomin\u00ae (IncobotulinumtoxinA) for the Treatment of Upper Limb Spasticity, Excluding Spasticity Caused by Cerebral Palsy [press release]. Merz 2020."},{"key":"10.3233\/PRM-210031_ref29","unstructured":"FDA approves Dysport for Therapeutic and Aesthetic Uses [press release]. Ipsen 2009."},{"key":"10.3233\/PRM-210031_ref30","unstructured":"FDA Approves Pediatric Indication for Xeomin\u00ae (IncobotulinumtoxinA) for the Treatment of Chronic Sialorrhea [press release]. Merz Therapeutics: Merz 2020."},{"issue":"3","key":"10.3233\/PRM-210031_ref31","doi-asserted-by":"publisher","first-page":"299","DOI":"10.1097\/01241398-199405000-00005","article-title":"Management of spasticity in cerebral palsy with botulinum-A toxin: report of a preliminary, randomized, double-blind trial","volume":"14","author":"Koman","year":"1994","journal-title":"J Pediatr Orthop."},{"issue":"3","key":"10.3233\/PRM-210031_ref32","doi-asserted-by":"publisher","first-page":"304","DOI":"10.1097\/00004694-199805000-00006","article-title":"Botulinum toxin A compared with stretching casts in the treatment of spastic equinus: a randomised prospective trial","volume":"18","author":"Corry","year":"1998","journal-title":"J Pediatr Orthop."},{"issue":"1","key":"10.3233\/PRM-210031_ref33","doi-asserted-by":"publisher","first-page":"67","DOI":"10.1016\/s0966-6362(99)00054-5","article-title":"Recommendations for the use of botulinum toxin type A in the management of cerebral palsy","volume":"11","author":"Graham","year":"2000","journal-title":"Gait Posture."},{"key":"10.3233\/PRM-210031_ref34","doi-asserted-by":"publisher","first-page":"88","DOI":"10.1046\/j.1468-1331.2001.00041.x","article-title":"Single event multilevel botulinum toxin type A treatment and surgery: similarities and differences","volume":"8","author":"Molenaers","year":"2001","journal-title":"Eur J Neurol."},{"key":"10.3233\/PRM-210031_ref35","doi-asserted-by":"publisher","first-page":"75","DOI":"10.1046\/j.1468-1331.2001.00040.x","article-title":"A randomized study of combined botulinum toxin type A and casting in the ambulant child with cerebral palsy using objective outcome measures","volume":"8","author":"Desloovere","year":"2001","journal-title":"Eur J Neurol."},{"key":"10.3233\/PRM-210031_ref36","doi-asserted-by":"publisher","DOI":"10.1097\/01.PSN.0000335818.00036.c5"},{"key":"10.3233\/PRM-210031_ref37","unstructured":"Botulinum gets black box warning. Pharmaceutical Representative. 2009; 39(6): 11."},{"key":"10.3233\/PRM-210031_ref40","unstructured":"FDA Approves Expanded BOTOX\u00ae (onabotulinumtoxinA) Label for the Treatment of Pediatric Patients with Spasticity [press release]. Abbvie 2020."},{"key":"10.3233\/PRM-210031_ref41","doi-asserted-by":"publisher","first-page":"91","DOI":"10.1055\/s-0035-1557199","article-title":"High dose of botulinum toxin type-A (BTX\/A): safety and efficacy in patients with cerebral palsy","author":"Awaad","year":"2004","journal-title":"Journal of Pediatric Neurology."},{"issue":"4","key":"10.3233\/PRM-210031_ref42","doi-asserted-by":"publisher","first-page":"234","DOI":"10.1017\/s0012162201000445","article-title":"Safety profile and efficacy of botulinum toxin A (Dysport) in children with muscle spasticity","volume":"43","author":"Bakheit","year":"2001","journal-title":"Dev Med Child Neurol."},{"issue":"10","key":"10.3233\/PRM-210031_ref43","doi-asserted-by":"publisher","first-page":"666","DOI":"10.1017\/s0012162201002730","article-title":"Botulinum toxin treatment of spasticity in diplegic cerebral palsy: a randomized, double-blind, placebo-controlled, dose-ranging study","volume":"44","author":"Baker","year":"2002","journal-title":"Dev Med Child Neurol."},{"key":"10.3233\/PRM-210031_ref44","unstructured":"Flowers CM, Kim I, Brinker A, Kortepeter C. Pediatric Postmarketing Pharmacovigilance Review: Dysport. Food and Drug Administration: Department of Health and Human Services, 2019."},{"issue":"13","key":"10.3233\/PRM-210031_ref45","doi-asserted-by":"publisher","first-page":"1058","DOI":"10.1177\/0883073817729918","article-title":"Safety and Efficacy of Repeat Open-Label AbobotulinumtoxinA Treatment in Pediatric Cerebral Palsy","volume":"32","author":"Delgado","year":"2017","journal-title":"J Child Neurol."},{"key":"10.3233\/PRM-210031_ref46","unstructured":"Dysport (abobotulinumtoxinA) [package insert]. U S Food and Drug Administration 2021."},{"key":"10.3233\/PRM-210031_ref47","unstructured":"Xeomin (incobotulinumtoxinA) [package insert]. U.S. Food and Drug Administration 2021."},{"issue":"4","key":"10.3233\/PRM-210031_ref48","doi-asserted-by":"publisher","first-page":"532","DOI":"10.1016\/j.ejpn.2016.04.008","article-title":"Safety profile of incobotulinum toxin A [Xeomin\u00ae] in gastrocnemius muscles injections in children with cerebral palsy: Randomized double-blind clinical trial","volume":"20","author":"Carraro","year":"2016","journal-title":"Eur J Paediatr Neurol"},{"issue":"1","key":"10.3233\/PRM-210031_ref49","doi-asserted-by":"publisher","first-page":"126","DOI":"10.1186\/s12883-020-01702-7","article-title":"IncobotulinumtoxinA for the treatment of spasticity in children with cerebral palsy \u2013 a retrospective case series focusing on dosing and tolerability","volume":"20","author":"Le\u00f3n-Valenzuela","year":"2020","journal-title":"BMC Neurol."},{"key":"10.3233\/PRM-210031_ref50","doi-asserted-by":"publisher","DOI":"10.1016\/j.mayocp.2012.04.017"},{"issue":"4","key":"10.3233\/PRM-210031_ref51","doi-asserted-by":"publisher","first-page":"296","DOI":"10.5863\/1551-6776-19.4.296","article-title":"Evaluation of Off-label Prescribing at a Children\u2019s Rehabilitation Center","volume":"19","author":"Luedtke","year":"2014","journal-title":"J Pediatr Pharmacol Ther."},{"key":"10.3233\/PRM-210031_ref52","unstructured":"Botox (onabotulinumtoxinA) [package insert]. US Food and Drug Administration 2021."},{"key":"10.3233\/PRM-210031_ref53","unstructured":"Medication Guides \u2013 Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS) [press release]. U.S. Department of Health and Human Services Food and Drug Administration\u00a0Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) 2011."},{"key":"10.3233\/PRM-210031_ref54","unstructured":"Code of Federal Regulations Title 21. Sect. Sec. 312.32 IND safety reporting. (2019)."},{"issue":"9237","key":"10.3233\/PRM-210031_ref55","doi-asserted-by":"publisher","first-page":"1255","DOI":"10.1016\/S0140-6736(00)02799-9","article-title":"Adverse drug reactions: definitions, diagnosis, and management","volume":"356","author":"Edwards","year":"2000","journal-title":"Lancet"},{"key":"10.3233\/PRM-210031_ref56","unstructured":"Dantrium (dantrolene sodium) capsules [package insert] JHP Pharmaceuticals, LLC. U.S. Food and Drug Administration 2011."},{"issue":"1-2","key":"10.3233\/PRM-210031_ref57","doi-asserted-by":"publisher","first-page":"65","DOI":"10.1159\/000370245","article-title":"Serious and long-term adverse events associated with the therapeutic and cosmetic use of botulinum toxin","volume":"95","author":"Yiannakopoulou","year":"2015","journal-title":"Pharmacology"},{"issue":"11","key":"10.3233\/PRM-210031_ref58","doi-asserted-by":"publisher","first-page":"1587","DOI":"10.1111\/dsu.12188","article-title":"Analysis of botulinum toxin products and litigation in the United States","volume":"39","author":"Korman","year":"2013","journal-title":"Dermatol Surg"},{"key":"10.3233\/PRM-210031_ref59","unstructured":"Allergan Agrees to Plead Guilty and Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botox\u00ae [press release]. The United States Department of Justice 2010."},{"key":"10.3233\/PRM-210031_ref60","unstructured":"Drake v. Allergan, Inc., 111 F. Supp 3d 562 (D.Vt. 2015)."},{"key":"10.3233\/PRM-210031_ref61","unstructured":"Wells ex rel. J.W. v. Allergan, Inc. (W.D. Okla. January 31, 2013)."},{"key":"10.3233\/PRM-210031_ref63","unstructured":"Drake v. Allergan, Inc., 63 F. Supp 3d 382 (D.Vt. 2014)."},{"key":"10.3233\/PRM-210031_ref64","unstructured":"Fortuna et al v. Allergan, Inc., (D. Vt. April 9, 2015)."},{"key":"10.3233\/PRM-210031_ref66","unstructured":"Dodge AM, Fitzer SF. When Good Doctors Get Sued: A Practical Guide for Physicians Involved in Malpractice Lawsuits. 3rd Edition ed: Dodge Consulting and Publication, 2009."},{"issue":"7","key":"10.3233\/PRM-210031_ref67","doi-asserted-by":"publisher","first-page":"563","DOI":"10.1001\/virtualmentor.2012.14.7.hlaw1-1207","article-title":"Informed consent: what must a physician disclose to a patient","volume":"14","author":"Murray","year":"2012","journal-title":"Virtual Mentor"},{"issue":"11","key":"10.3233\/PRM-210031_ref68","doi-asserted-by":"publisher","first-page":"4645","DOI":"10.3390\/toxins7114645","article-title":"Questionnaire about the adverse events and side effects following botulinum toxin A treatment in patients with cerebral palsy","volume":"7","author":"Blaszczyk","year":"2015","journal-title":"Toxins (Basel)."}],"container-title":["Journal of Pediatric Rehabilitation Medicine"],"original-title":[],"link":[{"URL":"https:\/\/content.iospress.com\/download?id=10.3233\/PRM-210031","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T04:39:30Z","timestamp":1777610370000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/full\/10.3233\/PRM-210031"}},"subtitle":[],"editor":[{"given":"Deborah","family":"Gaebler-Spira","sequence":"additional","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]},{"given":"Michael","family":"Green","sequence":"additional","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2021,6,25]]},"references-count":63,"journal-issue":{"issue":"2"},"URL":"https:\/\/doi.org\/10.3233\/prm-210031","relation":{},"ISSN":["1875-8894","1874-5393"],"issn-type":[{"value":"1875-8894","type":"electronic"},{"value":"1874-5393","type":"print"}],"subject":[],"published":{"date-parts":[[2021,6,25]]}}}