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Aggression in children treated with clobazam for epilepsy
R D Sheth1, K J Goulden, G M Ronen
1Department of Neurology, West Virginia University, Health Science Center, Morgantown 26506-9180, USA.
Insights
Clobazam (CLB) can cause severe behavioral disorders in children with refractory epilepsy, including agitation and insomnia. Discontinuing CLB resolved these adverse effects, highlighting the need for careful monitoring of this antiepileptic drug.
Area of Science:
- Pediatric Neurology
- Child Psychiatry
- Pharmacology
Background:
- Refractory epilepsy in children presents significant treatment challenges.
- Clobazam (CLB) is an antiepileptic drug used for managing difficult-to-treat seizures.
- Behavioral side effects of antiepileptic drugs require thorough investigation.
Purpose of the Study:
- To report on severe behavioral disorders observed in children treated with clobazam (CLB).
- To characterize the nature, onset, and resolution of these adverse behavioral events.
- To assess the impact of CLB on coadministered antiepileptic drug serum levels.
Main Methods:
- Observational study of 63 children with refractory epilepsy treated with CLB.
- Detailed recording of behavioral changes, onset latency, and CLB dosage.
- Monitoring of serum levels of other antiepileptic drugs during CLB therapy.
- Follow-up assessment of behavioral outcomes after CLB discontinuation.
Main Results:
- Eleven percent (7/63) of children developed severe behavioral disorders, including agitation, self-injury, insomnia, and motor hyperactivity.
- These adverse events occurred 10-55 days after initiating CLB, often at low dosages, in young, developmentally disabled children.
- Discontinuation of CLB led to behavioral improvement within 3 weeks, with no recurrence after over 3 years.
- CLB did not alter serum levels of concurrently administered antiepileptic drugs.
Conclusions:
- Clobazam (CLB) can induce severe behavioral disturbances in a subset of pediatric epilepsy patients.
- The behavioral changes are reversible upon drug discontinuation.
- The mechanism underlying CLB-induced behavioral deterioration remains unclear, warranting further research.
Abstract:
Seven of 63 children (11%) treated with clobazam (CLB) for refractory epilepsy developed a severe behavior disorder. This disorder was characterized by aggressive agitation, self injurious behavior, insomnia, and incessant motor activity occurring between 10 and 55 days after initiation of drug therapy. The affected children were relatively young (mean age 6.4 years) and developmentally disabled (four were autistic and two had isolated mental retardation). The disorder occurred with a short latency after initiation of therapy and at a relatively low dosage of CLB. Serum levels of other coadministered antiepileptic drugs were unchanged by the administration of CLB. One child was taking CLB monotherapy. This behavioral deterioration required the discontinuation of CLB, after which patients returned to their previous behavior within 3 weeks. After > 3 years of follow-up all children continue to require multiple antiepileptic drugs but have not had a recurrence of this aggressive agitation. The mechanism of the behavioral change is unclear.