The Australian Adverse Drug Reactions Advisory Committee (ADRAC) has considered the safety and efficacy of 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).

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.

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. 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.

3. Children and adolescents who are currently being treated for MDD with an SSRI should not have their medication ceased abruptly.

Reference: Statement from the Adverse Drug Reactions Advisory Committee, 11 March 2004 on http://health.gov.au/tga/