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Safety of Supratherapeutic Doses of Newer Antiepileptic Drugs in Children: What Have We Really Learned?

(FDA) approval is granted before adequate pediatric studies are performed. The pediatric neurologist is then in the awkward position of using the new medication prior to the availability of complete pharmacokinetic data. Pediatric neurologists have typically increased average and maximum adult daily doses by 40%–50% in pre-adolescent children, to approximate the adult dosage range (based on mg/kg/day). As Messinger et al1 point out, this often leads to proportionately larger doses being used in children. This has implications for adverse events (both serious and routine). The authors retrospectively reviewed their safety experience at Texas Children’s Hospital over a 4-year period, during which 41,137 prescriptions were written. Their primary objective was to determine the safety of exceeding FDA-suggested maximum adult doses for topiramate, lamotrigine, levetiracetam, oxcarbazepine, zonisamide, and clobazam. They found 166 patients (1.4% of the total) who were taking doses that exceeded the FDA recommended maximum adult dose for commonly used newer antiepileptic drugs. Importantly, the study did not have an increased incidence of adverse events. Levetiracetam was the drug most commonly prescribed at doses above those recommended for adults, and lamotrigine was the least commonly prescribed above the therapeutic dose. This is consistent with reports made to poison control centers, where levetiracetam was the lowest in rank for need for interventions, and lamotrigine was the highest.2 The authors concluded that it is safe to use doses of these specific antiepileptic drugs that exceeded the maximum FDA-approved dose. What lessons have we learned from this large, realworld review of the use of newer antiepileptic drugs in children? This trial validated several important concepts that are critical to keep in mind when treating children with epilepsy. Awareness of these concepts by the pediatric neurologists and pharmacists will improve their care of children with epilepsy.