behaviour (suicide attempts and suicidal ideation) has been reported
in patients treated with atomoxetine. In double-blind clinical
trials, suicide-related behaviours were uncommon, but more frequently
observed among children and adolescents treated with atomoxetine
compared to those treated with placebo, where there were no events.
double-blind clinical trials there was no difference in the frequency
of suicide-related behaviour between atomoxetine and placebo.
Patients who are being treated for ADHD should be carefully
monitored for the appearance or worsening of suicide-related
death and pre-existing cardiac abnormalities:
death has been reported in patients with structural cardiac
abnormalities who were taking atomoxetine at usual doses. Although
some serious structural cardiac abnormalities alone carry an
increased risk of sudden death, atomoxetine should only be used with
caution in patients with known serious structural cardiac
abnormalities and in consultation with a cardiac specialist.
can affect heart rate and blood pressure. Most patients taking
atomoxetine experience a modest increase in heart rate (mean <10
bpm) and/or increase in blood pressure (mean <5 mm Hg).
combined data from controlled and uncontrolled ADHD clinical trials
show that approximately 8-12% of children and adolescents, and 6-10%
of adults experience more pronounced changes in heart rate (20 beats
per minute or greater) and blood pressure (15-20 mmHg or greater).
Analysis of these clinical trial data showed that approximately
15-26% of children and adolescents, and 27-32% of adults experiencing
such changes in blood pressure and heart rate during atomoxetine
treatment had sustained or progressive increases. Long-term sustained
changes in blood pressure may potentially contribute to clinical
consequences such as myocardial hypertrophy.
a result of these findings, patients who are being considered for
treatment with atomoxetine should have a careful history and physical
exam to assess for the presence of cardiac disease, and should
receive further specialist cardiac evaluation if initial findings
suggest such history or disease.
is recommended that heart rate and blood pressure be measured and
recorded before treatment is started and, during treatment, after
each adjustment of dose and then at least every 6 months to detect
possible clinically important increases. For paediatric patients the
use of a centile chart is recommended.
should not be used in patients with severe cardiovascular or
cerebrovascular disorders. Atomoxetine should be used with caution in
patients whose underlying medical conditions could be worsened by
increases in blood pressure and heart rate, such as patients with
hypertension, tachycardia, or cardiovascular or cerebrovascular
who develop symptoms such as palpitations, exertional chest pain,
unexplained syncope, dyspnoea or other symptoms suggestive of cardiac
disease during atomoxetine treatment should undergo a prompt
addition, atomoxetine should be used with caution in patients with
congenital or acquired long QT or a family history of QT
orthostatic hypotension has also been reported, atomoxetine should be
used with caution in any condition that may predispose patients to
hypotension or conditions associated with abrupt heart rate or blood
with additional risk factors for cerebrovascular conditions (such as
a history of cardiovascular disease, concomitant medications that
elevate blood pressure) should be assessed at every visit for
neurological signs and symptoms after initiating treatment with
rarely, spontaneous reports of liver injury, manifested by elevated
hepatic enzymes and bilirubin with jaundice, have been reported. Also
very rarely, severe liver injury, including acute liver failure, have
been reported. STRATTERA should be discontinued in patients with
jaundice or laboratory evidence of liver injury, and should not be
or manic symptoms:
psychotic or manic symptoms, e.g., hallucinations, delusional
thinking, mania or agitation in patients without a prior history of
psychotic illness or mania can be caused by atomoxetine at usual
doses. If such symptoms occur, consideration should be given to a
possible causal role of atomoxetine, and discontinuation of treatment
should be considered. The possibility that STRATTERA will cause the
exacerbation of pre-existing psychotic or manic symptoms cannot be
behaviour, hostility or emotional lability:
(predominantly aggression, oppositional behaviour and anger) was more
frequently observed in clinical trials among children, adolescents
and adults treated with STRATTERA compared to those treated with
placebo. Emotional lability was more frequently observed in clinical
trials among children treated with STRATTERA compared to those
treated with placebo. Patients should be closely monitored
uncommon, allergic reactions, including anaphylactic reactions, rash,
angioneurotic oedema, and urticaria, have been reported in patients
are a potential risk with atomoxetine. Atomoxetine should be
introduced with caution in patients with a history of seizure.
Discontinuation of atomoxetine should be considered in any patient
developing a seizure or if there is an increase in seizure frequency
where no other cause is identified.
and development should be monitored in children and adolescents
during treatment with atomoxetine.
long-term therapy should be monitored and consideration should be
given to dose reduction or interrupting therapy in children and
adolescents who are not growing or gaining weight satisfactorily.
data do not suggest a deleterious effect of atomoxetine on cognition
or sexual maturation; however, the amount of available long-term data
is limited. Therefore, patients requiring long-term therapy should be
or worsening of Comorbid Depression, Anxiety and Tics:
a controlled study of paediatric patients with ADHD and comorbid
chronic motor tics or Tourette’s Disorder, atomoxetine-treated
patients did not experience worsening of tics compared to placebo-
treated patients. In a controlled study of adolescent patients with
ADHD and comorbid Major Depressive Disorder, atomoxetine-treated
patients did not experience worsening of depression compared to
placebo-treated patients. In two controlled studies (one in
paediatric patients and one in adult patients) of patients with ADHD
and comorbid anxiety disorders, atomoxetine-treated patients did not
have been rare postmarketing reports of anxiety and depression or
depressed mood and very rare reports of tics in patients taking
who are being treated for ADHD with atomoxetine should be monitored
for the appearance or worsening of anxiety symptoms, depressed mood
and depression or tics.
population under six years of age:
should not be used in patients less than six years of age as efficacy
and safety have not been established in this age group.
is not indicated for the treatment of major depressive episodes
and/or anxiety as the results of clinical trials in adults in these
conditions, where ADHD is not present, did not show an effect
compared to placebo.
Summary of Product Characteristics