Observational studyBMJ open2015
A prospective study of adverse drug reactions to antiepileptic drugs in children.
Observational study in BMJ open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
30 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Movement disorders associated with antiseizure medications: A systematic review.Epilepsy & behavior : E&B · 2022Pooled it
- Safety of Levetiracetam in Paediatrics: A Systematic Review.PloS one · 2016Pooled it
- Gabapentin and cognitive impairment after traumatic brain injury: A multinational cohort of 49,925 patients.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026Article
- Levetiracetam for Seizure Prophylaxis after Traumatic Brain Injury: A Severity-Stratified Cohort Study of 51,000 Patients.Annals of neurology · 2026Article
- Drug hypersensitivity reactions in children in clinical practice: A WAO Statement.The World Allergy Organization journal · 2025Review
- Analysis of the Recurrence of Adverse Drug Reactions in Pediatric Patients with Epilepsy.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Effects of tDCS on glutamatergic pathways in epilepsy: neuroprotective and therapeutic potential.Pflugers Archiv : European journal of physiology · 2025Article
- General ability and specific cognitive functions are lower in children with epilepsy after perinatal ischemic stroke.Frontiers in stroke · 2024Article
- Analysis of Adverse Drug Reactions in Pediatric Patients with Epilepsy: An Intensive Pharmacovigilance Study.Children (Basel, Switzerland) · 2023Article
- The Utility of Responsive Neurostimulation for the Treatment of Pediatric Drug-Resistant Epilepsy.Brain sciences · 2023Review
- Evaluation of risk factors for recurrence of cutaneous adverse reactions due to anti-seizure medications in children: A retrospective study.Current journal of neurology · 2023Article
- A real-life pilot study of the clinical application of pharmacogenomics testing on saliva in epilepsy.Epilepsia open · 2023Article
- Medical treatment in infants and young children with epilepsy: Off-label use of antiseizure medications. Survey Report of ILAE Task Force Medical Therapies in Children.Epilepsia open · 2023Article
- Pharmacovigilance in Pediatric Patients with Epilepsy Using Antiepileptic Drugs.International journal of environmental research and public health · 2022Article
- Patterns of Antiepileptic Drug Reactions in Children: A Multicenter Study.Iranian journal of child neurology · 2022Article
- Drug-Induced Severe Cutaneous Adverse Reactions: Insights Into Clinical Presentation, Immunopathogenesis, Diagnostic Methods, Treatment, and Pharmacogenomics.Frontiers in pharmacology · 2022Review
- A Standardized Electrode Nomenclature for Stereoelectroencephalography Applications.Journal of clinical neurophysiology : official publication of the American Electroencephalographic Society · 2021Article
- Parent-Reported Symptoms and Medications Used Among Children With Severe Neurological Impairment.JAMA network open · 2020Article
- A Scoping Review of Medications Studied in Pediatric Polypharmacy Research.Paediatric drugs · 2020Article
- Valproic Acid Induced Pancreatitis Presenting With Decreased Level of Consciousness in a Child With Tuberous Sclerosis Complex.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
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 OUTCOMES: Primary 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 NUMBER: EudraCT (2007-000565-37).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.