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Meta-analysis of suicide-related behavior events in patients treated with atomoxetine
Mark E Bangs1, Sitra Tauscher-Wisniewski2, John Polzer2
1All of the authors are with Lilly Research Laboratories, Eli Lilly and Company..
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.
Insights
Suicidal ideation occurred more often in pediatric ADHD patients taking atomoxetine than placebo. No suicides were reported in atomoxetine trials, but careful monitoring for ideation is crucial.
Area of Science:
- Pharmacovigilance
- Pediatric Psychiatry
- Clinical Trial Analysis
Background:
- Atomoxetine is a non-stimulant medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in pediatric patients.
- Assessing the risk of suicide-related events is critical for medications used in child and adolescent populations.
Observation:
- A meta-analysis of 14 pediatric trials examined suicide-related events in patients treated with atomoxetine.
- Suicidal ideation was observed in 0.37% of pediatric ADHD patients on atomoxetine versus 0% on placebo.
Findings:
- While no suicides occurred, suicidal ideation was significantly more frequent in the atomoxetine group (p=.016).
- No significant difference in suicide-related events was found between atomoxetine and methylphenidate treatments.
- The number needed to harm for a suicide-related event was 227, compared to a number needed to treat of five for ADHD symptom remission.
Implications:
- Pediatric patients with ADHD treated with atomoxetine require careful monitoring for suicidal ideation.
- The findings highlight the importance of balancing treatment efficacy with potential adverse events in pediatric psychopharmacology.
- Further research may be needed to understand the nuances of suicide-related events in this population.
