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• W2312050323 abstract "<h3>Objectives</h3> To 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. <h3>Setting</h3> A single centre prospective observational study. <h3>Participants</h3> Children (<18 years old) receiving one or more AEDs for epilepsy, at each clinically determined follow-up visit. <h3>Primary and secondary outcomes</h3> Primary outcome was adverse reactions of AEDs. Behavioural and cognitive functions were secondary outcomes. <h3>Results</h3> 180 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. <h3>Conclusions</h3> Behavioural problems and somnolence were the most common ADRs. Polytherapy significantly increases the likelihood of ADRs in children. <h3>Trail registration number</h3> EudraCT (2007-000565-37)." @default.
• W2312050323 created "2016-06-24" @default.
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• W2312050323 date "2015-06-01" @default.
• W2312050323 modified "2023-10-02" @default.
• W2312050323 title "A prospective study of adverse drug reactions to antiepileptic drugs in children" @default.
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• W2312050323 doi "https://doi.org/10.1136/bmjopen-2015-008298" @default.
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