Safety and tolerability of atomoxetine over 3 to 4 years in children and adolescents with ADHD.
OBJECTIVE
To assess the long-term safety and tolerability of atomoxetine hydrochloride in children and adolescents with attention-deficit/hyperactivity disorder treated for > or = 3 years.


METHODS
Data from 13 double-blind, placebo-controlled trials and 3 open-label extension studies were pooled. Outcome measures were patient-reported treatment-emergent adverse events (AEs); discontinuations due to AEs, serious AEs, and changes in body weight, height, vital signs, electrocardiogram, and hepatic function tests.


RESULTS
In total, 714 patients were treated with atomoxetine for > or = 3 years (mean follow-up 4.8 years [SD 1.1 years]), including a subset of 508 treated for > or = 4 years (mean follow-up 5.3 years [SD 0.8 years]). Most subjects were younger than 12 years at entry (73.8%), male (78.4%), and white (88.9%). The mean final daily dose of atomoxetine was 1.35 mg/kg (SD 0.37 mg/kg). No new or unexpected AEs were observed compared with acute-phase treatment. Less than 6% of patients exhibited aggressive/hostile behaviors, and less than 1.6% reported suicidal ideation/behavior. No clinically significant effects were seen on growth rate, vital signs, or electrocardiographic parameters, and < or = 2% of patients showed potentially clinically significant hepatic changes.


CONCLUSIONS
Atomoxetine was safe and well tolerated for children and adolescents with > or = 3 and/or > or = 4 years of treatment.
Donnelly
Craig
C
Department of Child & Adolescent Psychiatry, Dartmouth-Hitchcock Medical Center, 1 Rope Ferry Road, Hanover, NH 03755-1404, USA. Craig.L.Donnelly@Dartmouth.edu
Bangs
Mark
M
Trzepacz
Paula
P
Jin
Ling
L
Zhang
Shuyu
S
Witte
Michael M
MM
Ball
Susan G
SG
Spencer
Thomas J
TJ
D000293:Adolescent; D018759:Adrenergic Uptake Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D000374:Aggression / Q000187:drug effects; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy / Q000503:physiopathology*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006791:Hostility; D006801:Humans; D008297:Male; D011437:Propylamines / Q000008:administration & dosage* / Q000009:adverse effects; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome; D055986:Vital Signs / Q000187:drug effects
D018759:Adrenergic Uptake Inhibitors; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride