Meta-Analysis of Suicide-Related Behavior Events in Patients Treated With Atomoxetine
Abstract
Objective The present work examined suicide-related events in acute, double-blind, and placebo- or active comparator-controlled trials with atomoxetine.Method Fourteen trials in pediatric patients were included. Potential events were identified in the adverse events database using a text-string search. Potential suicide-related events were categorized according to U.S. Food and Drug Administration-defined codes using blinded patient summaries. The meta-analyses used the Mantel-Haenszel incidence difference and Mantel-Haenszel risk ratio methods.Results No patient in atomoxetine attention-deficit/hyperactivity disorder (ADHD) trials committed suicide. The frequency of suicidal ideation was 0.37% (5/1357) in pediatric patients taking atomoxetine versus 0% (0/851) for the placebo group; Mantel-Haenszel incidence difference of 0.46 (95% confidence interval 0.09-0.83; p =.016) and Mantel-Haenszel risk ratio of 2.92 (95% confidence interval 0.63-13.57; p =.172). Frequencies of suicide-related events in pediatric patients with ADHD did not differ between methylphenidate and atomoxetine treatments (Mantel-Haenszel incidence difference of -0.12 (95% confidence interval -0.62 to 0.38; p =.649). The number needed to harm in pediatric patients for an additional suicide-related event is 227 compared to the number needed to treat of five to achieve remission of ADHD symptoms.Conclusions Although uncommon, suicidal ideation was significantly more frequent in pediatric ADHD patients treated with atomoxetine compared to those treated with placebo. Retrospective analysis has limitations in ascertaining intent.
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Additional adverse effects of atomoxetine include initial somnolence, gastrointestinal tract symptoms (particularly if dosage is increased too rapidly), and decreased appetite.
“Additional adverse effects of atomoxetine include initial somnolence and gastrointestinal tract symptoms, particularly if the dosage is increased too rapidly, and decreased appetite.119–122”
From Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents (2019) · cites this paper as [121]
A meta-analysis of the data showed that suicidal ideation was more frequently observed in clinical trials among children and adolescents treated with atomoxetine (5/1,357) compared to those treated with placebo (0/851), with a number needed to harm (NNH) of 227 compared to the number needed to treat (NNT) of 5 to achieve remission of ADHD symptoms.
“A meta-analysis of the data showed that suicidal ideation was more frequently observed in clinical trials among children and adolescents treated with atomoxetine (5/1,357) compared to those treated with placebo (0/851), with a number needed to harm (NNH) of 227 compared to the number needed to treat (NNT) of 5 to achieve remission of ADHD symptoms [15].”
From European guidelines on managing adverse effects of medication for ADHD (2011) · cites this paper as [15]
There was one suicide attempt in the atomoxetine-treated group and no completed suicide occurred during the trials.
“There was one suicide attempt in the atomoxetine-treated group and no completed suicide occurred during the trials.”
From European guidelines on managing adverse effects of medication for ADHD (2011) · cites this paper as [15]
In adults treated with atomoxetine there was no evidence of increased suicidal risk.
“In adults treated with atomoxetine there was no evidence of increased suicidal risk.”
From European guidelines on managing adverse effects of medication for ADHD (2011) · cites this paper as [15]
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- Authors
- BANGS, M. E., TAUSCHER-WISNIEWSKI, S., POLZER, J., ZHANG, S., ACHARYA, N., DESAIAH, D., TRZEPACZ, P. T., & ALLEN, A. J.
- Affiliations
- Eli Lilly (United States) (US)
- Corresponding author
- BANGS, MARK E.
- ORCID
- ZHANG, SHUYU
- Venue
- Journal of the American Academy of Child & Adolescent Psychiatry
- Publisher
- Elsevier BV
- Published
- 2008-02
- Volume
- 47
- Issue
- 2
- Pages
- 209-218
- ISSN
- 0890-8567 (ISSN-L)
- OpenAlex
- W2007567296
- Cited by
- 152
- References
- 58
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 4 · 2023: 6 · 2022: 5 · 2021: 6 · 2020: 6 · 2019: 6 · 2018: 2 · 2017: 6 · 2016: 11 · 2015: 7 · 2014: 15 · 2013: 19 · 2012: 18
- FWCI
- 1.50
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of the American Academy of Child & Adolescent Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Social Sciences › Psychology › Clinical Psychology › Suicide and Self-Harm Studies
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Keywords
- atomoxetine, suicidal ideation, attention deficit hyperactivity disorder, pediatric patients, methylphenidate, adverse drug reactions, number needed to harm, number needed to treat
- MeSH terms
- Atomoxetine Hydrochloride, Adolescent, Attention Deficit Disorder with Hyperactivity, Child, Cross-Sectional Studies, Double-Blind Method, Female, Humans, Male, Propylamines, Suicide, Attempted, Adverse Drug Reaction Reporting Systems, Adrenergic Uptake Inhibitors, Controlled Clinical Trials as Topic
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