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ADVERSE DRUG REACTIONS (PowerPoint)

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




               Rajanagarindra Institute of Child Development
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.


                        Rajanagarindra Institute of Child Development
Background

 Prevalence of ADHD in children
  worldwide was estimated 7-10 %1, and
  3-5%2 in children in Thailand.
 Pharmaceutical costs was 42% higher

  than those of asthma.3
Drug therapy for ADHD

    Methylphenidate
    Atomoxetine
    Clonidine
    Bupropion
    Antidepressants
    TCAs
    Atypical   antipsychotics

                       Rajanagarindra Institute of Child Development
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


                      Rajanagarindra Institute of Child Development
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



                       Rajanagarindra Institute of Child Development
Adverse events associated with
atomoxetine HCl

 Abdominal pain            Irritability
 Constipation              Mood swings
 Dyspepsia                 Dry mouth
 Vomiting                  Nausea

 Weight loss               Appetite
 Dizziness                  decreased
 Somnolence                Insomnia

 Headache                    Cough

                   Rajanagarindra Institute of Child Development
Study Objective

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




                      Rajanagarindra Institute of Child Development
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.


                      Rajanagarindra Institute of Child Development
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.



                         Rajanagarindra Institute of Child Development
Results

 25 patients included in this study
 Average age 11 year (7-16)

 21 (84%) were male

 4 (16%) were female




                     Rajanagarindra Institute of Child Development
Atomoxetine Effectiveness

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



                             Rajanagarindra Institute of Child Development
Atomoxetine Effectiveness (cont.)

 At the end of the study 16 patients
  remained on atomoxetine.
 Effective maintenance dose was
  0.84±0.29 (0.33-1.51) mg/kg .
   5 patients had improved in attention and
    mood, but serious adverse effects occurred,
    parents decided to stop atomoxetine.

                        Rajanagarindra Institute of Child Development
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



                     Rajanagarindra Institute of Child Development
Time to event

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




                    Rajanagarindra Institute of Child Development
Discussion

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

                      Rajanagarindra Institute of Child Development
Reference
1.   Brown RT and Perrin JM. Measuring outcomes in attention-
     deficit/hyperactivity disorder. J of Ped Psychology. 2007;32(6): 627-
     630.
2.   Disease prevalence statistic report 2003. Department of Mental Health,
     Ministry of Public Health. Thailand. 2003.
3.   Kelleher K, Childs G, Harman J: Health costs for children with attention-
     deficit/hyperactivity disorder. Economics of Neuroscience 2001;3:60-63.
4.   Drug information for prescribing information submitted to US FDA. 2008.
     Eli Lilly and Company. Indianapolis, IN. USA.
5.   Drug information. Drug Information Handbook . 2005