Disclosures: Jacqueline Krieger, BS: No financial relationships or conflicts of interest

Background and/or Objectives: Background: Botulinum toxin is commonly used to treat muscle spasticity and sialorrhea. Prior to the FDA approved Botox dose maximum in 2019, there was a wide variability in dosing practice associated with chemodenervation in children.

Objectives: 1. To determine if the frequency of adverse events (AEs) of onabotulinumtoxin A (Botox) injections that exceeded the recent FDA-approved dose maximum was greater than those within the approved range at our institution. 2. To determine if the likelihood of AEs increased with higher doses of onabotulinumtoxin A injections.

Design: Retrospective case-control study

Setting: Large urban pediatric medical center

Participants: We analyzed 1,841 Botox injections administered to 638 patients, aged 4 months-22 years old.

Interventions: Not applicable

Main Outcome Measures: Frequency and severity of AEs reported within 3 months of injections.

Results: There were no serious AEs were observed in our sample. AEs were infrequent (2.5%) and most commonly pain at the injection site. There was no statistical difference between AEs following injections within (23 events of 636 injections) and exceeding (24 events of 1158 injections) FDA-approved doses of injected Botox (p=0.061 with lower rate of AEs in the injections that exceeded the approved dose maximum). The likelihood of AEs did not significantly increase with higher doses of Botox.

Conclusions: These results indicate that higher doses of injected Botox in a pediatric population may be safe to use. Further work to investigate the relationship between dose and efficacy is needed.

Level of Evidence: Level III

« Back to AAPM&R Annual Assembly 2022

PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/incidence-of-adverse-effects-of-onabotulinumtoxin-a-injections-in-a-pediatric-population/