Characteristics of adverse drug reactions associated with antiepileptics at a tertiary children's hospital in Japan: A retrospective observational cohort study

Epilepsy Res. 2021 Jul:173:106614. doi: 10.1016/j.eplepsyres.2021.106614. Epub 2021 Mar 11.

Abstract

Objective: The aim of this study was to explore the prescription pattern of antiepileptics and the relationship between antiepileptics and adverse drug reactions (ADRs) in a Japanese population.

Methods: A retrospective observational cohort study was conducted by reviewing the medical records of patients who visited or were admitted to a single tertiary care center between January 2011 and June 2019, were treated with antiepileptics, and developed allergic ADRs associated with these drugs.

Results: In total, 14,230 unique patients received antiepileptics during the study period. Diazepam was the most frequently used antiepileptic drug (74.8 %), followed by phenobarbital (14.3 %), valproic acid (11.4 %), fosphenytoin (10.0 %), and carbamazepine (7.3 %). Although a trend of increasing prevalence of newer generation antiepileptics was noted, most patients are still treated with older generation antiepileptics. Thirty-two (0.22 %) unique patients experienced ADRs associated with antiepileptics, and the antiepileptic drug most frequently associated with ADRs was carbamazepine, at a rate of 1.4 %. Three patients developed Stevens-Johnson syndrome/toxic epidermal necrolysis, in two of which carbamazepine was implicated. Most patients experienced ADRs associated with aromatic antiepileptics (84.4 %) or older generation antiepileptics (81.3 %).

Significance: This is the first study to assess the relationship between ADRs and antiepileptics at a tertiary care center in Japan. Based on our results, most patients were prescribed older generation antiepileptics, and most ADR events were linked to the administration of drugs in this category; thus, identification of patients at risk of developing ADRs is critical in order to prevent such events.

Keywords: Adverse drug reactions; Aromatic antiepileptics; Japanese; Newer generation antiepileptics; Older generation antiepileptics; Retrospective study.

Publication types

  • Observational Study

MeSH terms

  • Anticonvulsants* / adverse effects
  • Child
  • Humans
  • Japan / epidemiology
  • Retrospective Studies
  • Stevens-Johnson Syndrome*
  • Tertiary Care Centers

Substances

  • Anticonvulsants