European warning on Prozac for under-18s contravenes advice in Britain

April 26, 2005
by staff reporter

Prozac should not be prescribed to under-18s, the European medicines regulator has advised.

This is despite Prozac being approved for under-18s by Britain's drugs regulator, the Medicines and Healthcare products Regulatory Agency (MHRA)

Prozac and other SSRI (selective serotonin reuptake inhibitors) drugs can make some children and adolescents feel suicidal or become hostile and aggressive, the European Medicines Agency ruled yesterday

Reviews of clinical trials carried out on SSRIs with children show that they offer little benefit to weigh against the potentially life-threatening side-effects some under-18s experience.

The MHRA came to a similar conclusion in Britain in 2003. But it exempted Prozac, stating that the drug's benefits outweighed any risks.

The European decision means GPs and psychiatrists in Britain face conflicting advice.

The European Medicines Agency

See also:
Sept 21, 2004: Prozac must have suicide warning - advisers to the US Food and Drug Administration agree antidepressants can cause some young people to become suicidal.
Dec 14, 2003: Doctors told not to prescribe SSRI antidepressants to under 18s - but should we listen to the new advice? ask some psychiatrists

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