title: Seizure risk in patients with attention-deficit-hyperactivity disorder treated with atomoxetine.
abstract: The comorbidity of seizures, epilepsy, and attention-deficit-hyperactivity disorder (ADHD) prompted the examination of whether atomoxetine use for ADHD is associated with an increased risk of seizures. Seizures and seizure-related symptoms were reviewed from two independent Eli Lilly and Company databases: the atomoxetine clinical trials database and the atomoxetine postmarketing spontaneous adverse event database. Review of clinical trial data indicated that the crude incidence rates of seizure adverse events were between 0.1 and 0.2%, and were not significantly different between atomoxetine, placebo, and methylphenidate. Only 2% of the postmarketing spontaneous reports of seizure events were classified as having no clear contributing or confounding factors, and the reporting rate (8 per 100 000 patients exposed) was within the expected range of population-based incidence. Although children with ADHD are increasingly recognized as being at an elevated risk for seizures, treatment of ADHD symptoms with atomoxetine does not appear to elevate this risk further. The shared vulnerability between ADHD and seizure activity should be taken into account when making treatment decisions for populations of children with epilepsy and children with ADHD.
authors.affiliation: Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.
authors.forename: Joachim F
authors.initials: JF
authors.lastname: Wernicke
authors.forename: Karen Chilcott
authors.initials: KC
authors.lastname: Holdridge
authors.forename: Ling
authors.initials: L
authors.lastname: Jin
authors.forename: Timothy
authors.initials: T
authors.lastname: Edison
authors.forename: Shuyu
authors.initials: S
authors.lastname: Zhang
authors.forename: Mark E
authors.initials: ME
authors.lastname: Bangs
authors.forename: Albert J
authors.initials: AJ
authors.lastname: Allen
authors.forename: Susan
authors.initials: S
authors.lastname: Ball
authors.forename: David
authors.initials: D
authors.lastname: Dunn
mesh_terms: D000293:Adolescent; D018759:Adrenergic Uptake Inhibitors / Q000009:adverse effects*; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy; D002648:Child; D002675:Child, Preschool; D016208:Databases, Factual / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D008297:Male; D015201:Meta-Analysis as Topic; D008774:Methylphenidate / Q000627:therapeutic use; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data; D011437:Propylamines / Q000009:adverse effects*; D012306:Risk; D012640:Seizures / Q000139:chemically induced* / Q000453:epidemiology*
chemical_list: D018759:Adrenergic Uptake Inhibitors; D011437:Propylamines; D008774:Methylphenidate; D000069445:Atomoxetine Hydrochloride