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Published on: September 20, 2024
Behavioral Adverse Effects During Initial Six Weeks of Levetiracetam Therapy in Children with Epilepsy: A Prospective
Saphibanrisa Rea Shabong1, Devendra Mishra2, Monica Juneja1,3
1Department of Pediatrics, Maulana Azad Medical College (University of Delhi), 2, BSZ Marg, Delhi, 110002, India.
Insights
Levetiracetam use in children with epilepsy may lead to behavioral issues, particularly at higher doses. Close monitoring for neurobehavioral effects is recommended for pediatric patients on this anti-seizure medication.
Area of Science:
- Pediatric Neurology
- Clinical Pharmacology
- Child Psychiatry
Background:
- Epilepsy is a common neurological disorder in children.
- Levetiracetam is a widely used anti-seizure medication (ASM).
- Understanding the behavioral side effects of ASMs in pediatric populations is crucial.
Purpose of the Study:
- To evaluate behavioral adverse effects of levetiracetam in drug-naïve children with epilepsy.
- To assess these effects whether levetiracetam is used as monotherapy or polytherapy.
Main Methods:
- Prospective cohort study in a pediatric hospital.
- Enrolled 60 drug-naïve children (4-12 years) with epilepsy initiating levetiracetam.
- Assessed behavior using SDQ and CBCL at baseline, 14 days, and 6 weeks.
Main Results:
- No baseline behavioral problems were observed.
- 11.7% of children showed behavioral problems by 6 weeks.
- Higher levetiracetam doses (>30 mg/kg/day) correlated significantly with increased behavioral issues.
Conclusions:
- Close neurobehavioral monitoring is necessary for children with epilepsy on levetiracetam.
- Particular attention should be paid to those receiving higher dosages.
- Levetiracetam's behavioral impact warrants careful consideration in pediatric epilepsy management.
Objective:
To assess the behavioral adverse effects associated with the use of levetiracetam in drug-naïve children with epilepsy, either as monotherapy or as part of anti-seizure medications polytherapy.
Methods:
This prospective cohort study was conducted in the pediatrics department of a public hospital from October 3, 2024, to July 26, 2025. Typically developing children aged 4-12 years with epilepsy were consecutively enrolled, if they were being planned to be initiated on levetiracetam therapy, either as monotherapy or as an add-on therapy. Behavioral problems were assessed prior to starting levetiracetam using Strength and Difficulties Questionnaire (SDQ) and Child Behavior Checklist (CBCL) and repeated at 14 (+ 3) days and 6 (+ 1) weeks of follow-up.
Results:
The study included 60 children with mean (SD) age of 7.75 (2.48) years. At enrollment, behavioral problems were not observed in any child (scores in the normal range). Proportion of those with behavioral problems in any sub-domain in either of the tools at follow-up was 3.3% at 14 days and 11.7% (95% CI 5.77-22.18%) at 6 weeks. Behavioral problems based on total scores, of either tool, were present in 6.7% (95% CI 2.6-16.0%) at 6-week follow-up. Behavioral adverse effects were found to be statistically associated with use of higher doses of levetiracetam (> 30 mg/kg/day), with dose and total CBCL scores [r (95% CI) = 0.542 (0.33-0.70); P < 0.001] and total SDQ scores [r (95% CI) = 0.515 (0.30-0.68); P < 0.001] showing significant correlation. The discontinuation rate was 1.7% (n = 1).
Conclusion:
There is a need of close surveillance for neurobehavioral morbidity in children with epilepsy receiving levetiracetam, especially those receiving high doses.
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