Meta-analysis of suicide-related behavior events in patients treated with atomoxetine.
OBJECTIVE
The present work examined suicide-related events in acute, double-blind, and placebo- or active comparator-controlled trials with atomoxetine.


METHODS
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.
Bangs
Mark E
ME
All of the authors are with Lilly Research Laboratories, Eli Lilly and Company.. Electronic address: bangsme@lilly.com.
Tauscher-Wisniewski
Sitra
S
All of the authors are with Lilly Research Laboratories, Eli Lilly and Company.
Polzer
John
J
All of the authors are with Lilly Research Laboratories, Eli Lilly and Company.
Zhang
Shuyu
S
All of the authors are with Lilly Research Laboratories, Eli Lilly and Company.
Acharya
Nayan
N
All of the authors are with Lilly Research Laboratories, Eli Lilly and Company.
Desaiah
Durisala
D
All of the authors are with Lilly Research Laboratories, Eli Lilly and Company.
Trzepacz
Paula T
PT
All of the authors are with Lilly Research Laboratories, Eli Lilly and Company.
Allen
Albert J
AJ
All of the authors are with Lilly Research Laboratories, Eli Lilly and Company.
D000293:Adolescent; D018759:Adrenergic Uptake Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D016907:Adverse Drug Reaction Reporting Systems; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D002648:Child; D018849:Controlled Clinical Trials as Topic; D003430:Cross-Sectional Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D011437:Propylamines / Q000009:adverse effects* / Q000627:therapeutic use; D013406:Suicide, Attempted / Q000523:psychology / Q000706:statistics & numerical data*
D018759:Adrenergic Uptake Inhibitors; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride