EMEA backs Prozac for children

The European Medicines Agency (EMEA) has backed the use of fluoxetine (Prozac) in children over eight years old for the treatment of moderate to severe depression.

If the European Commission licenses fluoxetine for this indication, it will mean the SSRI will no longer be prescribed to children and adolescents off-label.

All other SSRIs are considered inappropriate for this age group because of fears of increased suicidal behaviour.

The EMEA said children with moderate to severe depression were eligible for the treatment if they had shown no response to between four and six sessions of psychological therapy. But any pharmacotherapy should be accompanied by further psychological therapy.

Doctors and parents were warned to monitor children and adolescents taking fluoxetine for signs of suicidal behaviour.

The European recommendations mirror NICE guidelines on the treatment of depression in children and young people.

NICE said that for children aged 5-11 with moderate to severe depression who did not respond to psychological therapy, 'the addition of fluoxetine should be cautiously considered'.

However, France has called on the EMEA to carry out an arbitration review because of unresolved safety concerns.

The data reviewed by the EMEA included three studies involving over 750 children and adolescents with depression.

Dr Alan Cohen, south London GP and director of primary care at the Sainsbury Centre for mental health, said that, regardless of the recommendations, GPs should not give fluoxetine to children without specialist supervision.

'Most GPs really do need to refer to a specialist initially,' he said.

North Shields GP Dr Dave Tomson, a consultant in patient-centred primary care, said that GPs should, for the most part, avoid initiating this treatment in primary care. 'I would exercise caution, given previous experience with SSRIs in children.'

Meanwhile, the MHRA has updated its prescribing advice for the antidepressant venlafaxine (Efexor). Specialist supervision is now only required for initiation of treatment, unless the patient is hospitalised or on a daily dose of 300mg.

rachel.liddle@haynet.com

EMEA ruling

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