Atomoxetine safety update

Published in Medicinewise Living

Date published: About this date

Atomoxetine (brand name Strattera) is a medicine used to treat Attention Deficit Hyperactivity Disorder (ADHD), a behavioural disorder that affects concentration in children, adolescents and adults.

Atomoxetine (the active ingredient in Strattera) is known to cause mood changes, which in a very small number of people may lead to thoughts of harming themselves and potentially an increased risk of suicide.

Why has a safety update been issued for atomoxetine?

The Therapeutic Goods Administration (or TGA, the medicines regulatory body in Australia) has advised that since 2004, a total of 74 people taking atomoxetine, including children and teenagers, have reported psychiatric disorders.

More than half of these reports (42) were of people — including 28 children aged 6 to18 years — who had thoughts about suicide. Two children attempted suicide and one, a 9-year-old, took his own life while taking atomoxetine.

A study of 12 clinical trials showed that while there is an increased risk of suicidal thoughts in children and adolescents taking atomoxetine compared with those taking a placebo (an inactive pill), the increased risk of suicidal thoughts is extremely small (5 out of 1357 people [0.4%] compared with 0 out of 851 [0%] people taking the placebo). Only one suicide attempt was reported in someone taking atomoxetine.

Why has my doctor prescribed atomoxetine?

Atomoxetine is usually only prescribed for people with severe ADHD. However, your doctor may prescribe atomoxetine if you, or your child, have tried other medicines for ADHD and you have experienced serious side effects, or if your doctor believes that other medicines are not suitable for you or your child.

Before prescribing atomoxetine, your doctor will discuss the benefits and risks of atomoxetine with you. Always ask your doctor about all your treatment options, and their benefits and risks.

Not everyone with ADHD needs to take a medicine. Medicines are usually prescribed only for people whose ADHD is significantly negatively affecting their normal daily functioning. Psychological and social therapies are often used alone or together with medicines to manage ADHD.

I am taking atomoxetine — what do I need to know?

If you are taking atomoxetine, and especially if your dose has changed, seek medical advice if you notice that you:

  • are hyperactive
  • are irritable
  • are confused or have hallucinations
  • have thoughts of death or suicide
  • have thoughts of harming yourself or others
  • have recently or previously attempted to harm yourself.

My child is taking atomoxetine — what should I look out for?

If your child is taking atomoxetine, be alert for sudden changes in their mood or behaviour, especially in the first few months after starting atomoxetine or after a change in dose.

Tell your doctor immediately or go to the nearest hospital if you notice any changes in your child’s behaviour, especially if they are:

  • anxious
  • depressed
  • agitated or restless
  • experiencing panic attacks
  • unable to sleep (insomnia)
  • irritable
  • hostile
  • aggressive
  • acting on dangerous impulses
  • extremely active or won’t stop talking (manic behaviour).

Talk with your child and listen to their thoughts and feelings. Tell your doctor if your child talks about death or harming themselves, or if they do attempt to harm themselves or others.

Ask other carers such as teachers, relatives and older siblings to also watch for worrying moods and behaviours in your child.

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