title: Questionnaire about the adverse events and side effects following botulinum toxin A treatment in patients with cerebral palsy.
abstract: Botulinum toxin A (BoNT-A) injections for treatment of spasticity in patients with cerebral palsy (CP) have been used for about two decades. The treatment is considered safe but a low frequency of adverse events (AE) has been reported. A good method to report AEs is necessary to verify the safety of the treatment. We decided to use an active surveillance of treatment-induced harm using a questionnaire we created. We studied the incidence of reported AEs and side effects in patients with CP treated with BoNT-A. We investigated the relationship between the incidence of AEs or side effects and gender, age, weight, total dose, dose per body weight, Gross Motor Function Classification System (GMFCS) and number of treated body parts. Seventy-four patients with CP participated in our study. In 54 (51%) of 105 BoNT-A treatments performed in 45 (61%) patients, there were 95 AEs and side effects reported, out of which 50 were generalized and/or focal distant. Severe AEs occurred in three patients (4%), and their BoNT-A treatment was discontinued. Consecutive collection of the AE and side-effect incidence using our questionnaire can increase the safety of BoNT-A treatment in patients with CP.
authors.affiliation: Department of Hand and Plastic Surgery, University Hospital of Northern Sweden, 90 185 Umea, Sweden. belizabla@gmail.com.
authors.forename: Izabela
authors.initials: I
authors.lastname: Blaszczyk
authors.affiliation: Department of Hand and Plastic Surgery, University Hospital of Northern Sweden, 90 185 Umea, Sweden. nazlifoumani@gmail.com.
authors.forename: Nazli Poorsafar
authors.initials: NP
authors.lastname: Foumani
authors.affiliation: Department of Hand and Plastic Surgery, University Hospital of Northern Sweden, 90 185 Umea, Sweden. christina.ljungberg@umu.se.
authors.forename: Christina
authors.initials: C
authors.lastname: Ljungberg
authors.affiliation: Department of Hand and Plastic Surgery, University Hospital of Northern Sweden, 90 185 Umea, Sweden. mikael.pj.wiberg@umu.se.
authors.forename: Mikael
authors.initials: M
authors.lastname: Wiberg
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D001835:Body Weight; D019274:Botulinum Toxins, Type A / Q000009:adverse effects* / Q000627:therapeutic use; D002547:Cerebral Palsy / Q000150:complications* / Q000188:drug therapy; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004421:Dystonia / Q000188:drug therapy; D005260:Female; D006801:Humans; D015994:Incidence; D007223:Infant; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000188:drug therapy; D009465:Neuromuscular Agents / Q000009:adverse effects* / Q000627:therapeutic use; D011446:Prospective Studies; D015203:Reproducibility of Results; D012737:Sex Factors; D011795:Surveys and Questionnaires; D055815:Young Adult
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A
keywords: adverse events; botulinum toxin type A; cerebral palsy; muscle spasticity; safety