Safety and tolerability profile of new antiepileptic drug treatment in children with epilepsy

Romina Moavero, Laura Rosa Pisani, Francesco Pisani, Paolo Curatolo

Research output: Contribution to journalReview articlepeer-review


INTRODUCTION: Treatment of pediatric epilepsy requires a careful evaluation of the safety and tolerability profile of antiepileptic drugs (AEDs) to avoid or minimize as much as possible adverse events (AEs) on various organs, hematological parameters, and growth, pubertal, motor, cognitive and behavioral development. Areas covered: Treatment-emergent AEs (TEAEs) reported in the literature 2000-2018 regarding second- and third-generation AEDs used in the pediatric age, with exclusion of the neonatal period that exhibits specific peculiarities, have been described on the basis of their frequency, severity/tolerability, and particular association with a given AED. Expert opinion: Somnolence/sedation and behavioral changes, like irritability and nervousness, are among the most commonly observed TEAEs associated with almost all AEDs. Lamotrigine, Gabapentin, Oxcarbazepine, and Levetiracetam appear to be the best-tolerated AEDs with a ≤2% withdrawal rate, while Tiagabine and Everolimus are discontinued in up to >20% of the patients because of intolerable TEAEs. For some AEDs, literature data are scanty to draw a high-level evidence on their safety and tolerability profile. The reasons are: insufficient population size, short duration of treatments, or lack of controlled trials. A future goal is that of identifying clearer, easier, and more homogeneous methodological strategies to facilitate AED testing in pediatric populations.

Original languageEnglish
Pages (from-to)1015-1028
Number of pages14
JournalExpert Opinion on Drug Safety
Issue number10
Publication statusPublished - Oct 2018


  • Age Factors
  • Anticonvulsants/administration & dosage
  • Child
  • Child Behavior/drug effects
  • Epilepsy/drug therapy
  • Humans
  • Sleep Stages/drug effects


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