Original articleAdverse effects following botulinum toxin A injections in children with cerebral palsySapienza, Marcoa,b; Kapoor, Rahulc; Alberghina, Flaviad; Maheshwari, Ratnac; McCracken, Kathryn Louisee; Canavese, Federicob; Johari, Ashok N.c Author Information aDepartment of General Surgery and Medical Surgical Specialties, Section of Orthopaedics and Traumatology, P.O. ‘Policlinico Gaspare Rodolico’, University of Catania, Catania, Italy bDepartment of Pediatric Orthopedic Surgery, Jeanne de Flandre Hospital, Lille University Centre, Lille, France cChildren’s Orthopaedic Centre, Mumbai, India dPediatric Orthopaedic Department, Children’s Health Ireland, Dublin eUniversity College Cork School of Medicine, Cork, Ireland Received 16 March 2022 Accepted 25 December 2022. A.J. and F.C. designed the study; F.A., F.C., and R.K. collected the data; M.S., R.K., and R.M. analyzed data; F.A., F.C., and K.M. drafted the work; A.J., F.C., and K.M. reviewed the manuscript. All authors approved the final version to be published. Correspondence to Federico Canavese, MD, PhD, Department of Pediatric Orthopedic Surgery, Lille University Center, Jeanne de Flandre Hospital, Rue Eugène Avinée, 59000 Lille France, Tel: +33 3 20446867; e-mail: [email protected] Journal of Pediatric Orthopaedics B ():10.1097/BPB.0000000000001055, January 19, 2023. | DOI: 10.1097/BPB.0000000000001055 Buy PAP Metrics Abstract The study aimed to analyze the adverse events associated with botulinum toxin A (BoNT-A) injections in children with cerebral palsy (CP). The literature search was completed using the Medline, PubMed, Google Scholar, Scopus, and Cochrane Library databases from the earliest date possible up to December 2021. Search terms included ‘botulinum toxin’, ‘cerebral palsy’, ‘spasticity’, ‘adverse effects’, ‘side effects’, ‘undesirable effects’, ‘complications’, ‘lower limb’, ‘upper limb’, and ‘children’ including combinations of index and free-text terms. Fifty-five studies were included in the study. Data on 6333 pediatric patients and more than 14 080 BoNT-A injections were collected. Respiratory symptoms and respiratory tract infections were the most frequently registered adverse events (AEs). Other common AEs included procedural/focal AEs, flu-like symptoms, and asthenia. Sentinel events including four cases of death were reported. AEs were more frequent and severe in high-dose patients; however, the capacity of BoNT-A to spread systemically remains unclear. Since severe adverse events are not common, further research is needed to collect more definitive clinical and homogeneous data to support the findings of the present research and clarify the safety profile of BoNT-A, especially regarding the incidence of respiratory issues and complications in GMFCS IV or V patients. Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.