Adverse Events of Atomoxetine in a Double-Blind Placebo-Controlled Study in Children with Autism

Tumuluru, Rameshwari V.; Corbett-Dick, Patricia; Aman, Michael G.; Smith, Tristram; Arnold, L. Eugene; Pan, Xueliang; Buchan-Page, Kristin A.; Brown, Nicole V.; Ryan, Melissa M.; Hyman, Susan; Hellings, Jessica A.; Williams, C.; Hollway, Jill A.; Lecavalier, Luc; Rice, Robert R.; McAuliffe-Bellin, Sarah; Handen, Benjamin L.

doi:10.1089/cap.2016.0187

Cited by 16 publications

(14 citation statements)

References 20 publications

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“…Tumuluru et al reported in detail about the adverse effects seen during RCT conducted by Handen et al The authors report increased incidence of non-serious adverse events like decreased appetite and fatigue associated with atomoxetine in children with ASD as compared to TD children. However, there was no incidence of any serious adverse events and authors conclude that atomoxetine is as safe in children with ASD as it is in TD children [Tumuluru et al, 2017]. As reported by authors of the RCT, our meta-analysis also did not find significant difference of serious adverse events in atomoxetine as compared to placebo [Tumuluru et al, 2017].…”

Section: Discussionsupporting

confidence: 68%

“…However, there was no incidence of any serious adverse events and authors conclude that atomoxetine is as safe in children with ASD as it is in TD children [Tumuluru et al, 2017]. As reported by authors of the RCT, our meta-analysis also did not find significant difference of serious adverse events in atomoxetine as compared to placebo [Tumuluru et al, 2017]. However, the rate of non-serious side effects is higher in terms of higher risk of gastrointestinal side effects; more than twothird of trial participants experienced decreased appetite and about 50% patients complained of nausea/vomiting.…”

Section: Discussionmentioning

confidence: 92%

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Atomoxetine for attention deficit hyperactivity disorder in children and adolescents with autism: A systematic review and meta‐analysis

et al. 2019

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Atomoxetine is prescribed to children with autism spectrum disorder having symptoms of attention deficit hyperactivity disorder. We sought to examine the efficacy and safety of atomoxetine in this population. After screening for inclusion criteria, we identified three randomized placebo controlled trials involving 241 children. We assessed internal validity using standard Cochrane Risk of bias tool for randomized controlled trials (RCTs). We used Revman 5.3 for meta‐analysis and GRADE approach to create summary of findings with grading of the quality of evidence. Atomoxetine had a benefit on improving parent‐rated hyperactivity (standardized mean difference [SMD] = −0.73, 95% Confidence Interval, CI = −1.15 to −0.34) and parent‐rated inattention (SMD = −0.53, 95% CI = −0.93 to −0.12) but the magnitude of effects is uncertain. However, atomoxetine was also associated with increased risk of non‐serious adverse effects like nausea and vomiting, decreased sleep, and decreased appetite. Atomoxetine may be effective in improving hyperactivity and inattention in children with autism spectrum disorder and attention deficit hyperactivity disorder. However, we are uncertain about the true effect of this intervention and need more RCTs trials designed to evaluate this. Autism Research 2019, 12: 542–552. © 2019 International Society for Autism Research, Wiley Periodicals, Inc. Lay Summary Atomoxetine is prescribed for Attention Deficit Hyperactivity Disorder (ADHD). About a third of children and adolescents with autism also suffer from ADHD. We carried out an analysis of data reported from a specific kind of medication trials which had examined the effectiveness and side effects of atomoxetine in this patient population. We could find only three such trials and analyzed the reported data. Our analysis revealed that atomoxetine is effective in improving symptoms of ADHD like hyperactivity and inattention and also causes side effects like nausea, vomiting, decreased sleep, and decreased appetite. However, the existing data are insufficient to provide a conclusive statement with certainty and more trials are needed for this.

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Section: Discussionsupporting

confidence: 68%

Section: Discussionmentioning

confidence: 92%

Atomoxetine for attention deficit hyperactivity disorder in children and adolescents with autism: A systematic review and meta‐analysis

et al. 2019

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“…For anti‐ADHD medications, we included three NMAs 49,144,145 , 11 MAs 146‐156 , 12 RCTs 157‐168 also included in those NMA/MAs, five additional RCTs 169‐173 , and five cohort studies 99,174‐177 . There were 148,664 youth on anti‐ADHD medications, including 28,834 across 298 RCTs after eliminating duplicated RCTs in multiple NMA/MAs (27,188 in NMA/MAs, 1,646 in additional RCTs), and 119,830 in five cohort studies.…”

Section: Resultsmentioning

confidence: 99%

Safety of 80 antidepressants, antipsychotics, anti‐attention‐deficit/hyperactivity medications and mood stabilizers in children and adolescents with psychiatric disorders: a large scale systematic meta‐review of 78 adverse effects

et al. 2020

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Mental disorders frequently begin in childhood or adolescence. Psychotropic medications have various indications for the treatment of mental disorders in this age group and are used not infrequently off‐label. However, the adverse effects of these medications require special attention during developmentally sensitive periods of life. For this meta‐review, we systematically searched network meta‐analyses and meta‐analyses of randomized controlled trials (RCTs), individual RCTs, and cohort studies reporting on 78 a priori selected adverse events across 19 categories of 80 psychotropic medications – including antidepressants, antipsychotics, anti‐attention‐deficit/hyperactivity disorder (ADHD) medications and mood stabilizers – in children and adolescents with mental disorders. We included data from nine network meta‐analyses, 39 meta‐analyses, 90 individual RCTs, and eight cohort studies, including 337,686 children and adolescents. Data on ≥20% of the 78 adverse events were available for six antidepressants (sertraline, escitalopram, paroxetine, fluoxetine, venlafaxine and vilazodone), eight antipsychotics (risperidone, quetiapine, aripiprazole, lurasidone, paliperidone, ziprasidone, olanzapine and asenapine), three anti‐ADHD medications (methylphenidate, atomoxetine and guanfacine), and two mood stabilizers (valproate and lithium). Among these medications with data on ≥20% of the 78 adverse events, a safer profile emerged for escitalopram and fluoxetine among antidepressants, lurasidone for antipsychotics, methylphenidate among anti‐ADHD medications, and lithium among mood stabilizers. The available literature raised most concerns about the safety of venlafaxine, olanzapine, atomoxetine, guanfacine and valproate. Nausea/vomiting and discontinuation due to adverse event were most frequently associated with antidepressants; sedation, extrapyramidal side effects, and weight gain with antipsychotics; anorexia and insomnia with anti‐ADHD medications; sedation and weight gain with mood stabilizers. The results of this comprehensive and updated quantitative systematic meta‐review of top‐tier evidence regarding the safety of antidepressants, antipsychotics, anti‐ADHD medications and mood stabilizers in children and adolescents can inform clinical practice, research and treatment guidelines.

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“…In a recent double-blind placebo-controlled trial in children with ASD, the atomoxetine group showed an improvement in hyperactivity symptoms, with side effects of only fatigue and reduced appetite [35].…”

Section: Stimulants and Non-stimulantsmentioning

confidence: 99%

Pharmacobiological Treatments in Autism Spectrum Disorders

Jayaraman¹,

Mundkur²

2017

IJCRR

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Autism spectrum disorders (ASD) refer to a group of neuro-developmental disorders affecting young children and adults. Currently, the treatment options for ASD are mostly restricted to treating its symptoms. Among the various approaches for treating ASD, pharmacobiology-based treatments are numerous. Our objective is to review the up-to-date information on different types of medications and briefly discuss the evidence-based potential of these treatments in ASD therapy. PubMed searches for reports and reviews on clinical data from the last 15 years, between 2002-2017, using search terms of each category of treatment along with the terms "autism", "mechanism", and/or "side effects" were conducted. Several pharmacobiological interventions have been prescribed for ASD, including antipsychotics, stimulants, antidepressants, supplements, and special diets. However, none of these methods is an effective ASD treatment, and only few show much promise. We provide a brief overview of the current pharmacobiological treatments for ASD, their mechanisms of action, and clinical research-based evidence on their effectiveness. Based on our review, we recommend that caution should be exercised when choosing a pharmacobiological treatment method for ASD as majority of existing evidence is not from large-scale long-term high quality studies.Future research should focus on rigorous investigative design, long-term implementation, and meaningful uniform outcome measurements.

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Adverse Events of Atomoxetine in a Double-Blind Placebo-Controlled Study in Children with Autism

Abstract: This study extends the findings of previous studies of ATX in ASD by documenting that the type of AEs was similar to that of TD children, with no significant safety concerns.

Cited by 16 publications

References 20 publications

Atomoxetine for attention deficit hyperactivity disorder in children and adolescents with autism: A systematic review and meta‐analysis

Atomoxetine for attention deficit hyperactivity disorder in children and adolescents with autism: A systematic review and meta‐analysis

Safety of 80 antidepressants, antipsychotics, anti‐attention‐deficit/hyperactivity medications and mood stabilizers in children and adolescents with psychiatric disorders: a large scale systematic meta‐review of 78 adverse effects

Pharmacobiological Treatments in Autism Spectrum Disorders

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