A prospective study of adverse drug reactions to antiepileptic drugs in children

Abstract

ObjectivesTo prospectively determine the nature and rate of adverse drug reactions (ADRs) in children on antiepileptic drugs (AEDs) and to prospectively evaluate the effect of AEDs on behaviour.SettingA single centre prospective observational study.ParticipantsChildren (<18 years old) receiving one or more AEDs for epilepsy, at each clinically determined follow-up visit.Primary and secondary outcomesPrimary outcome was adverse reactions of AEDs. Behavioural and cognitive functions were secondary outcomes.Results180 children were recruited. Sodium valproate and carbamazepine were the most frequently used AEDs. A total of 114 ADRs were recorded in 56 of these children (31%). 135 children (75%) were on monotherapy. 27 of the 45 children (60%) on polytherapy had ADRs; while 29 (21%) of those on monotherapy had ADRs. The risk of ADRs was significantly lower in patients receiving monotherapy than polytherapy (RR: 0.61, 95% CI 0.47 to 0.79, p<0.0001). Behavioural problems and somnolence were the most common ADRs. 23 children had to discontinue their AED due to an ADR.ConclusionsBehavioural problems and somnolence were the most common ADRs. Polytherapy significantly increases the likelihood of ADRs in children.Trail registration numberEudraCT (2007-000565-37).

Assessment of quality of life in patients on antiepileptic drugs: a hospital based cross sectional study

“…Similar observations have been reported by Shobhana Mathur et al 12 Also similar results have been reported by other studies also. [13][14][15] This shows that the pattern of pharmacological therapy for epilepsy in these studies was similar to our study.…”

Intensive Monitoring of Adverse Drug Reactions to Antiepileptic Drugs in Neurology Department of a Secondary Care Hospital in U.A.E

“…These studies have identified ADRs in 4.67%-31% in patients receiving different AEDs. [8][9][10][11][12] There is a scarce in the published data regarding the incidence and pattern of ADRs to different AEDs in the local population. With this background, the main aim of the study was to identify and evaluate the ADRs associated with different antiepileptic drugs based on preventability, predictability and severity.…”

Monotherapy or polytherapy for childhood epilepsies?

“…In a prospective study, Anderson et al 15 reported a significantly higher risk of adverse drug reactions (ADRs) in children receiving polytherapy than monotherapy. Aggregated safety reports for lamotrigine in children have also shown that the risks of developing most ADRs are lower with monotherapy than polytherapy 16.…”