TGA home page


TGA - Therapeutic Goods Administration
Regulating Australia's medicines, medical devices, blood, tissues and chemicals
Home | About TGA | Contact TGA | A-Z guide | Sitemap
Advanced search  


   - Prescription
   - Non-prescription
   - Complementary

 Medical devices

 Blood & tissues



 Recalls & alerts

 Report problems


 Gene technology



Use of SSRI antidepressants in children and adolescents

11 March 2004

The Australian Adverse Drug Reactions Advisory Committee (ADRAC) has considered the safety and efficacy of the Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants* in children and adolescents. There is international concern about a possibility of increased suicidal ideation and self-harm behaviour provoked by the use of these drugs for the treatment of major depressive disorder (MDD).

ADRAC has considered the recent evaluation by the UK Committee on Safety of Medicines (CSM) and the briefing papers provided recently to a US Food and Drug Administration (FDA) Advisory Committee. ADRAC has also sought advice from the Royal Australian and New Zealand College of Psychiatrists and the Royal Australasian College of Physicians Division of Paediatrics & Child Health.

It should be noted that none of the SSRIs is approved for the treatment of MDD in children or adolescents in Australia, but these drugs are being used for this purpose. Two SSRIs (fluvoxamine and sertraline) are approved in Australia for the treatment of obsessive-compulsive disorder (OCD) in children and adolescents.

Top of page

The evaluations of clinical data from 11 trials in MDD in children and adolescents by the CSM and FDA are in broad agreement. These evaluations conclude there is evidence for efficacy of fluoxetine and possibly for citalopram, but not for fluvoxamine, paroxetine, sertraline, or venlafaxine. The evaluations also concluded there is evidence for increased suicidal ideation and/or behaviour for citalopram, paroxetine, sertraline, and venlafaxine. The CSM concluded the risk-benefit ratio was adverse for all the SSRIs except fluoxetine and the FDA issued strong advice against paroxetine use in children and adolescents.

Increases in suicidal ideation and behaviour during the early stages of antidepressant treatment are well-known clinical phenomena in adults. It is clear that this can occur in children and adolescents as well. The clinical trial evidence in children and adolescents is being analysed further, but seems to suggest that the increase in rate of suicidal thoughts and behaviour is low, and variable between studies.

Top of page

ADRAC considers that the current data are not conclusive regarding the efficacy and safety of SSRIs in MDD in children and adolescents. With this in mind, ADRAC recommends:

  1. Any SSRI use in children and adolescents with MDD should be undertaken only within the context of comprehensive management of the patient, as outlined in the NHMRC Clinical Practice Guidelines for Depression in Young People (1997). Such management should include careful monitoring for the emergence of suicidal ideation and behaviour.
  2. The choice of an SSRI for children or adolescents with MDD should be made only after taking into account the recent evaluations of clinical trial data and the Product Information. Note that the current Australian Product Information for paroxetine and venlafaxine recommends against their use in children and adolescents.
  3. Children and adolescents who are currently being treated for MDD with an SSRI should not have their medication ceased abruptly.

ADRAC will keep this issue under review.

Associate Professor Duncan Topliss
Chair, Adverse Drug Reactions Advisory Committee

11 March 2004

* the SSRI antidepressants are citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, and the related drug venlafaxine, which inhibits both noradrenaline reuptake and serotonin reuptake

Get Adobe Reader PDF iconYou need to have the Adobe Reader installed on your computer to view the PDF files on this website. The Adobe Reader is available free of charge from Adobe's website. If you have problems viewing the files, see our PDF Help page.



Top of Page | Home

Copyright | Security | Disclaimer | Privacy Statement