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Regulator restricts use of SSRIs in children

London Lynn Eaton

The European Medicines Agency has ruled that selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and norepinephrine reuptake inhibitors (SNRIs) should not be prescribed for children and adolescents under the age of 18, except for limited, approved uses. Some of the drugs have been approved for obsessive compulsive disorder, and one of them has been approved for attention deficit/hyperactivity disorder.

It is also recommending that strong warnings should be issued throughout the European Union about the potential risk of suicidal behaviour and aggression in these age groups.

The advice comes two months after a study in the BMJ said that people aged under 18 taking SSRIs were more likely to harm themselves than those taking a tricyclic antidepressant (BMJ 2005;330:389).

The agency’s ruling follows a review of the two classes of antidepressants published after a meeting 10 days ago at which its scientific committee concluded that these drugs should not be used in children, except in their approved indications. The drugs are primarily licensed for the treatment of depression and anxiety in adults, and are not licensed for the treatment of depression in children and adolescents.

The review was set up at a request of the European Commission made on 17 December 2004. The agency was already looking at the use of paroxetine (Seroxat) in children but widened the scope of its investigations to include all SSRIs and SNRIs after the commission’s request. It included all preparations containing atomoxetine, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, mianserin, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, and venlafaxine.

The agency’s committee for medicinal products for human use concluded that in clinical trials suicide related behaviour and hostility were more often seen among children and adolescents treated with these drugs than in those treated with placebo.

The agency has said it recognises that a doctor may sometimes make a decision to use these products to treat depression or anxiety in children or adolescents on the basis of individual clinical needs.

"In these cases patients should be monitored carefully for the appearance or suicidal behaviour, self-harm or hostility, particularly at the beginning of treatment," the committee advises.

It also warns against sudden withdrawal of the drug, saying that the dose should be reduced gradually over weeks or even months.

In October the US Food and Drug Administration directed manufacturers to include a "black box" label warning about all antidepressants and the risk of suicidal thoughts and suicide attempts in children (BMJ 2004;329:936).

The UK Medicines and Healthcare Products Regulatory Agency has already issued warnings about the risk of self harm and suicidal thoughts in young people taking the drugs (BMJ 2004;328:3-4).

A question and answer document on the subject is available at www.emea.eu.int
  
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