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Use of atomoxetine and suicidal ideation in children and adolescents: Results of an observational cohort study within general practice in England

Published online by Cambridge University Press:  23 March 2020

M. Davies ,
A. Coughtrie ,
D. Layton  and
S.A.S. Shakir
M. Davies*
Affiliation:
Drug safety research unit, Bursledon hall, Blundell lane, SO31 1AASouthampton, United Kingdom University of Portsmouth, PortsmouthUnited Kingdom
A. Coughtrie
Affiliation:
Drug safety research unit, Bursledon hall, Blundell lane, SO31 1AASouthampton, United Kingdom
D. Layton
Affiliation:
Drug safety research unit, Bursledon hall, Blundell lane, SO31 1AASouthampton, United Kingdom University of Portsmouth, PortsmouthUnited Kingdom
S.A.S. Shakir
Affiliation:
Drug safety research unit, Bursledon hall, Blundell lane, SO31 1AASouthampton, United Kingdom University of Portsmouth, PortsmouthUnited Kingdom
*
*Corresponding author. Drug safety research unit, Bursledon hall, Blundell lane, Southampton, SO31 1AA, United Kingdom. Tel.: +44 0 23 8040 8600; fax: +44 0 23 8040 8609. E-mail address:miranda.davies@dsru.org (M. Davies).
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Abstract

Aim

To investigate the association between atomoxetine, a drug used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD), and suicidal ideation, within a cohort of 2–18-year-old patients in England.

Methods

The study was conducted using the observational cohort technique of Modified prescription event monitoring (M-PEM). Patients prescribed atomoxetine were identified from dispensed prescriptions issued by primary care physicians. A customised postal GP questionnaire was used to capture outcome data for suicidal ideation. A matched pair cohort analysis was performed within patients to compare the risk of suicidal ideation in the period after starting atomoxetine with the risk prior to starting atomoxetine; this was stratified by age and concomitant use of methylphenidate. Additional information on patient characteristics, and events of interest was also collected; individual cases of suicidal ideation were qualitatively assessed for drug relatedness.

Results

Of the final cohort (n = 4509); 85.5% male (n = 3857), median age 11 years (IQR: 9,14). Primary prescribing indication for atomoxetine was ADHD (n = 4261, 94.6%). Almost a quarter of the cohort had been co-prescribed methylphenidate. Results of the matched pair cohort analysis indicated that the period after starting atomoxetine was not associated with an increase in the incidence of suicidal ideation compared to the period prior to starting treatment (RR: 0.71; CI: 0.48–1.07; P-value: 0.104). Individual case assessment of suicidal ideation suggested a causal association within a number of cases.

Conclusions

This study found no evidence of an increased risk of suicidal ideation during treatment with atomoxetine, compared to the period prior to starting treatment. Amongst age specific subgroups, this risk may change. Nonetheless, individual case assessment suggested a causal relationship in some patients, hence physicians need to be aware of the possibility of developing this event, and furthermore consider how best to detect it in this paediatric population. This study demonstrates the importance of combining quantitative statistical analyses with a qualitative case series assessment.

Keywords

Attention deficit disorder with hyperactivityAtomoxetineSuicidal ideationDrug-related side effects and adverse reactionsDrug utilisation
Type
Original article
Information
European Psychiatry , Volume 39 , January 2017 , pp. 11 - 16
Copyright
Copyright © Elsevier Masson SAS 2017

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