{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T11:38:55Z","timestamp":1788349135977,"version":"build-2803163510"},"reference-count":40,"publisher":"BMJ","issue":"6","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2015,5,7]]},"published-print":{"date-parts":[[2015,5]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>A single centre prospective observational study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>Children (&lt;18\u2005years old) receiving one or more AEDs for epilepsy, at each clinically determined follow-up visit.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Primary and secondary outcomes<\/jats:title>\n                    <jats:p>Primary outcome was adverse reactions of AEDs. Behavioural and cognitive functions were secondary outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>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&lt;0.0001). Behavioural problems and somnolence were the most common ADRs. 23 children had to discontinue their AED due to an ADR.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Behavioural problems and somnolence were the most common ADRs. Polytherapy significantly increases the likelihood of ADRs in children.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trail registration number<\/jats:title>\n                    <jats:p>EudraCT (2007-000565-37).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2015-008298","type":"journal-article","created":{"date-parts":[[2015,6,2]],"date-time":"2015-06-02T11:51:33Z","timestamp":1433245893000},"page":"e008298","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":60,"title":["A prospective study of adverse drug reactions to antiepileptic drugs in children"],"prefix":"10.1136","volume":"5","author":[{"given":"Mark","family":"Anderson","sequence":"first","affiliation":[{"name":"Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby, 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