Nootjaree Kamduang, B'Pharm' And Penkarn Kanjanarat, Ph'D'

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Nootjaree Kamduang, B'Pharm' And Penkarn Kanjanarat, Ph'D'

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Title: Nootjaree Kamduang, B'Pharm' And Penkarn Kanjanarat, Ph'D'

1
Effectiveness and Adverse Drug Events Related to
Atomoxetine Use in Children with Attention
Deficit Hyperactivity Disorder (ADHD) A Case
Series

Nootjaree Kamduang, B.Pharm. And Penkarn
Kanjanarat, Ph.D.
Rajanagarindra Institute of Child Development,
Chiang Mai University
Chiang Mai, Thailand

2
There is no conflict of interest to be declared
in this study.
3
Background

Attention-deficit/hyperactivity disorder (ADHD)
is a condition of the brain that makes it hard
for children to control their behavior.
ADHD is chronic health condition and prevalence
in children which affect morbidity and their
quality of life and parents quality of life.

4
Background

Prevalence of ADHD in children worldwide was
estimated 7-10 1, and 3-52 in children in
Thailand.
Pharmaceutical costs was 42 higher than those of
asthma.3

5
Drug therapy for ADHD

Methylphenidate
Atomoxetine
Clonidine
Bupropion
Antidepressants
TCAs
Atypical antipsychotics

6
Atomoxetine

Atomoxetine is a selective norepinephrine
reuptake inhibitor used for treating ADHD.
First approved in 2002 in the USA
Approved at 03/08/2005 with NC category by Thai
FDA
2008 First line drug for ADHD in children 6-18
years

7
Mechanism of Action

The precise mechanism of atomoxetine in ADHD is
unknown
It is thought to be related to selective
inhibition of the pre-synaptic norepinephrine
transporter4

8
Adverse events associated with atomoxetine HCl

Abdominal pain
Constipation
Dyspepsia
Vomiting
Weight loss
Dizziness
Somnolence
Headache

Irritability
Mood swings
Dry mouth
Nausea
Appetite decreased
Insomnia
Cough

9
Study Objective

To examine the effectiveness and adverse drug
events related to atomoxetine use in children
with ADHD

10
Methods

A case series study of atomoxetine use in
childhood patients with ADHD was conducted using
retrospective chart review
Subjects inpatients and outpatients diagnosed
with ADHD from 1 June 2006 to 30 April 2008 and
were prescribed with atomoxetine at least on one
visit.

11
Methods (cont.)

Study was conducted at the Rajanagarindra
Institute of Child Development, a psychiatric
tertiary care institute, Department of Mental
Health, MOPH, Chiang Mai, Thailand.
Data were analyzed using descriptive statistics.

12
Results

25 patients included in this study
Average age 11 year (7-16)
21 (84) were male
4 (16) were female

13
Atomoxetine Effectiveness

21 patients were reported to have positive
responses
Improvements in ADHD symptoms include
Attention
Study performance
Mood
Communication
Social skills

14
Atomoxetine Effectiveness (cont.)

At the end of the study 16 patients remained on
atomoxetine.
Effective maintenance dose was 0.840.29
(0.33-1.51) mg/kg .
5 patients had improved in attention and mood,
but serious adverse effects occurred, parents
decided to stop atomoxetine.

15
ADEs related to Atomoxetine

9 patients with weight loss
7 with aggressiveness
5 with nausea/vomiting
5 with somnolence
5 with headache
3 with mood irritation

16
Time to event

The average time to events in the patients with
ADEs or noncompliance was 7 months.

17
Discussion

Reasons to initiate atomoxetine mostly related to
adverse drug reactions of previous medication
mostly methylphenidate,
e.g., tics, weight loss and noncompliance.

18
Discussion

Atomoxetine is first-line drug however patients
have to pay for the medication. It is not
included in the National Essential Drug Lists.
This may be related to loss of follow-up in some
patients.
Average maintenance dose in the study patients
was lower than recommended dose of 1.2 mg/kg5 .

19
Conclusion

Atomoxetine was effective in the treatment of
ADHD in childhood.
However, the incidence of adverse drug events was
considerably high.
The use of atomoxetine in children with ADHD
should be closely monitored to improve adherence
and reduce the adverse drug event rate.

20
Reference

Brown RT and Perrin JM. Measuring outcomes in
attention-deficit/hyperactivity disorder. J of
Ped Psychology. 200732(6) 627-630.
Disease prevalence statistic report 2003.
Department of Mental Health, Ministry of Public
Health. Thailand. 2003.
Kelleher K, Childs G, Harman J Health costs for
children with attention-deficit/hyperactivity
disorder. Economics of Neuroscience 2001360-63.
Drug information for prescribing information
submitted to US FDA. 2008. Eli Lilly and Company.
Indianapolis, IN. USA.
Drug information. Drug Information Handbook .
2005