A pharmacovigilance study on antiepileptic medications in a paediatric hospital in Italy.

Objective: The standard treatment for epilepsy is based on the appropriate use of antiseizure medications (ASMs) to prevent the recurrence of seizures. For the newer ASMs, however, little information on their safety profile is available. This work sought to fill this gap by creating a database for ASM use in a paediatric hospital and the adverse drug reactions (ADRs) reported.

Methods: This observational single-centre study was conducted from January 2018 to December 2020 and recorded the type of ASM treatment for paediatric epileptic patients cared for at the Neuropsychiatry Unit of the Salesi Paediatric Hospital in Ancona, Italy, as well as any ADRs.

Results: In all, 519 patients were admitted to the ward with a diagnosis of epilepsy, 362 (69.7%) of whom were prescribed ASMs. Valproic acid was the most frequently prescribed drug (29.96%), followed by levetiracetam (13.97%) and carbamazepine (9.16%). We recorded 24 ADRs in 20 patients, half of which (n=12) occurred with polytherapy. Among the ADRs associated with monotherapy, 25% (n=6) were induced by carbamazepine; 12.5% (n=3) were associated with either valproic acid, clonazepam or lamotrigine; 8.3% (n=2) were associated with perampanel, clobazam or levetiracetam; while one patient experienced ADR due to vigabatrin, one due to ethosuximide and one due to cannabidiol. The median patient age was 7.5 years and most ADRs were not serious.

Conclusion: During the 3-year observation period, 6% of epileptic patients on ASMs showed one or more ADRs. Carbamazepine was responsible for about a quarter of these reactions, two of which were serious. Half of the ADRs occurred with polytherapy, which often included valproic acid and stiripentol. It is to be hoped that such active pharmacovigilance through the collaboration of hospital pharmacists and physicians will serve to improve the management of treatment.