Children and Adolescent Exposures to Atomoxetine Hydrochloride Reported to a Poison Control Center

Stojanovski, Sasko D.; Robinson, Renee; Baker, S. David; Casavant, Marcel J.; Hayes, J. R.; Nahata, Milap C.

doi:10.1080/15563650600584311

Cited by 16 publications

(17 citation statements)

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“…Various adverse clinical effects were reported to occur in a portion of atomoxetine ingestions, particularly when the drug is not taken as directed (Eli Lilly and Company, 2006;Stojanovski et al, 2006;Lackey et al, 2005a;Spiller et al, 2005). The most frequently reported adverse clinical effects in children and adolescents are drowsiness, tachycardia, nausea, vomiting, dizziness, dyspepsia, and agitation (Eli Lilly and Company, 2006;Stojanovski et al, 2006;Lackey et al, 2005a;Spiller et al, 2005).…”

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confidence: 92%

“…Several studies examined potentially adverse atomoxetine exposures among children and adolescents reported to poison control centers in the United States (Stojanovski et al, 2006;Lackey et al, 2005a;Spiller et al, 2005). However, these studies included data collected over at most two years and all involved relatively small numbers of cases.…”

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confidence: 96%

“…The most frequently reported adverse clinical effects in children and adolescents are drowsiness, tachycardia, nausea, vomiting, dizziness, dyspepsia, and agitation (Eli Lilly and Company, 2006;Stojanovski et al, 2006;Lackey et al, 2005a;Spiller et al, 2005). Other observed adverse clinical effects include constipation, dry mouth, decreased appetite, somnolence, nervousness, insomnia, depression, tremor, pruritus, mydriasis, headache, cough, and rash (Eli Lilly and Company, 2006;Stojanovski et al, 2006;Lackey et al, 2005a;Spiller et al, 2005;Michelson et al, 2001Michelson et al, , 2003Wernicke & Katchochvil, 2002). Suicidal ideation (having thoughts of suicide or of taking action to end one's own life) and liver injury were reported in a few instances (Lim et al, 2006;Wooltorton, 2005).…”

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confidence: 99%

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Pediatric Atomoxetine Ingestions Reported to Texas Poison Control Centers, 2003–2005

Forrester

2007

Journal of Toxicology and Environmental Health, Part A

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Limited information exists on potentially adverse consequences following pediatric atomoxetine ingestions reported to poison control centers. Using pediatric atomoxetine ingestions reported to Texas poison control centers during 2003-2005, the proportion of cases involving serious outcomes (medical outcomes classified as moderate effects, major effects, death, or judged as potentially toxic exposures) was determined for selected variables and evaluated for statistical significance by calculating the rate ratio (RR) and 95% confidence interval (CI). Of 501 cases identified, 31 (6%) involved serious outcomes. Higher serious outcome rates were found with a maximum dose of >2.8 mg/kg or >200 mg or >4 tablets. Serious outcome rates were also higher if the exposure involved intentional self-harm or the patient was already at or en route to a health care facility when the poison control center was contacted or referred to a health care facility by the poison control center. The severity of the outcome associated with pediatric atomoxetine ingestions was dependent upon the dose and the circumstances of the ingestion (whether intentional self-harm was involved). The management of patients with serious outcomes was more likely to involve health care facilities. This information is useful for creating triage guidelines for the management of pediatric atomoxetine ingestions.

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confidence: 92%

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confidence: 96%

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confidence: 99%

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Pediatric Atomoxetine Ingestions Reported to Texas Poison Control Centers, 2003–2005

Forrester

2007

Journal of Toxicology and Environmental Health, Part A

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“…[61][62][63][64] Doses to 6.25 mg/kg, 61 to 249 ± 326 mg, 62 and to 1200 mg 63 have been reported. In some reports, adverse drug reactions did not correlate with atomoxetine dose.…”

Section: Atomoxetine and Overdosementioning

confidence: 99%

“…64 No major outcomes or fatalities have been reported. 62,63 However, exposures have caused GI upset, lethargy [61][62][63] and seizures in one child, 62 and seizures in one adolescent female who ingested 2840 mg of atomoxetine in a suicide attempt; serum atomoxetine level of 1995 ng/mL. 65 Cardiovascular sequela has included sinus tachycardia, and increased blood pressure.…”

Section: Atomoxetine and Overdosementioning

confidence: 99%

Atomoxetine for the treatment of attention-deficit/hyperactivity disorder in children and adolescents: a review

Hammerness¹,

McCarthy²,

Mancuso³

et al. 2009

NDT

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Objective: This review examines and summarizes the pharmacodynamic and pharmacokinetic properties, short-and longer-term effi cacy, the moderating effect of comorbid disorders, as well as short-and long-term safety and tolerability of atomoxetine for the treatment of pediatric attention-defi cit/hyperactivity disorder (ADHD). Methods: A systematic literature search was performed to review the extant literature on articles pertaining to the pharmacological treatment with atomoxetine in pediatric and/or adolescent ADHD. Results: There is an extensive literature on atomoxetine; over 4000 children have participated in clinical trials of atomoxetine, demonstrating its short-and longer-term effi cacy. In addition, studies have examined the moderating effect of comorbid disorders on atomoxetine response, as well as atomoxetine's therapeutic potential for other psychiatric conditions. Short-and longerterm safety and tolerability continue to be reported. Conclusions: Atomoxetine is indicated for both acute and maintenance/extended treatment of pediatric ADHD. Clinicians and families must be familiar with atomoxetine's evidence base, including its profi le of clinical response and its possible effectiveness in the presence of comorbidity.

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Risk of Serious Cardiovascular Problems with Medications for Attention-Deficit Hyperactivity Disorder

et al. 2012

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Attention-deficit hyperactivity disorder (ADHD) is a chronic neurodevelopmental disorder characterized by persistent symptoms of inattention, hyperactivity and/or impulsivity. The proportion of patients diagnosed with ADHD receiving pharmacological treatments has increased enormously in recent years. Despite the well established efficacy and the good safety and tolerability profile, there is concern about the potential for rare but serious cardiovascular adverse events, as well as sudden cardiac death, with pharmacotherapies used for treating ADHD in children, adolescents and adults. The present paper aims to comprehensively and critically review the published evidence on the controversial association between medications approved for treating patients with ADHD and the risk of serious cardiovascular problems, specifically the risk of corrected QT interval (QTc) prolongation, and the risk of sudden cardiac death. A comprehensive search of relevant databases (PubMed, EMBASE and PsychINFO) was conducted to identify studies published in peer-reviewed journals until 21 July 2012. Clinical reports, as well as retrospective or prospective population-based studies with children, adolescents or adults as participants, of pharmacotherapies for ADHD reporting cardiovascular adverse events were included. Stimulant medications for ADHD, including methylphenidate and amphetamine derivatives, are generally safe and well tolerated. Small but statistically significant increases in blood pressure (BP) and heart rate (HR) are among the adverse events of stimulant treatment in all age groups. Similarly, the non-stimulant medication atomoxetine has also been associated with increased HR and BP, although as is the case with stimulants, these are generally minor, time limited and of minor clinical significance in children, adolescents or adults. Growing evidence suggests that these medications do not cause sudden and unexpected cardiac death or serious cardiovascular problems including statistically or clinically significant increases in QTc, at therapeutic doses in ADHD patients across the lifespan. Small decreases in mean systolic BP, diastolic BP and HR have been observed in studies with guanfacine-extended release (-XR) or clonidine-XR, two α(2)-adrenergic receptor agonists, administered alone or in combination with psychostimulants to children and adolescents with ADHD. There are also no statistically or clinically significant increases in QTc associated with clonidine or guanfacine. There are no reports of torsades de pointes clearly and directly related to medications used for treating ADHD in patients of all age groups. The risk for serious cardiovascular adverse events, including statistically or clinically significant increases in QTc, and sudden cardiac death associated with stimulants, atomoxetine or α(2)-adrenergic agonists prescribed for ADHD is extremely low and the benefits of treating individual patients with ADHD, after an adequate assessment, outweigh the risks. However, great caution is advised when considering stim...

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Children and Adolescent Exposures to Atomoxetine Hydrochloride Reported to a Poison Control Center

Abstract: At the doses reported, adverse drug reactions did not correlate with atomoxetine dose. Hypertension may occur in some patients following atomoxetine overdose.

Cited by 16 publications

References 11 publications

Pediatric Atomoxetine Ingestions Reported to Texas Poison Control Centers, 2003–2005

Pediatric Atomoxetine Ingestions Reported to Texas Poison Control Centers, 2003–2005

Atomoxetine for the treatment of attention-deficit/hyperactivity disorder in children and adolescents: a review

Risk of Serious Cardiovascular Problems with Medications for Attention-Deficit Hyperactivity Disorder

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