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SSRI antidepressants: Actions by the Therapeutic Goods Administration concerning use of antidepressants in children and adolescents

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15 October 2004

All current Precaution statements in the Product Information for all the SSRI antidepressants were updated earlier in 2004 but are being reviewed again in the light of FDA analyses.

The sponsors of all other antidepressants including the tricyclic group of antidepressants which were not specifically reviewed by the FDA are being asked to add adequate precautionary statements.

The Consumer Medicine Information documents in Australia will be reviewed to ensure that they convey similar information to patients and carers as is expected to be found in the US Medication Guides.

ADRAC believes that there is a need for comprehensive expert clinical guidance for prescribers in addition to those actions that can be taken by the TGA as the medicines regulator. ADRAC has already requested the Royal Australian and New Zealand College of Psychiatrists and the Royal Australian College of Physicians to conjointly co-ordinate the drawing up of this guidance.

ADRAC has recommended further educational initiatives for Australian prescribers be undertaken through the Australian Adverse Drug Reactions Bulletin and through the National Prescribing Service. The TGA agrees and will implement the recommendation.

A revised statement by ADRAC is being published on the TGA website on Friday, October 15.

Note: None of the SSRIs, and indeed no antidepressant, is currently approved in Australia for the treatment of MDD in children and adolescents (persons aged less than 18 years). Fluoxetine, but none of the other SSRIs, is approved in the US for MDD in young people without a specified lower age limit. Two of the SSRIs, fluvoxamine and sertraline, are approved in Australia for children and adolescents with obsessive compulsive disorder (OCD). The SSRI antidepressants included are citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine and sertraline, and the related medicine, venlafaxine.

John McEwen
Principal Medical Adviser
15 October 2004