Serotonin-specific reuptake inhibitors and serotonin-noradrenaline reuptake inhibitors

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

The European Medicines Agency has completed its review of two classes of antidepressants and concluded that they should not be used in children and adolescents except in their approved indications.

The review of serotonin-selective reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) medicines looked at the potential risk of suicidal behaviour in children and adolescents treated with these products.

The Agency's scientific committee, the Committee for Medicinal Products for Human Use (CHMP), concluded at its 19-22 April 2005 meeting that suicide-related behaviour (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with these antidepressants compared to those treated with placebo.

The Agency's committee is therefore recommending the inclusion of strong warnings across the whole of the European Union to doctors and parents about these risks. Doctors and parents will also be advised that these products should not be used in children and adolescents except in their approved indications.

Most of these products are approved for the treatment of depression and anxiety in adults in the European Union, but are not licensed Europe-wide for the treatment of these conditions in children or adolescents. Some of these products are however licensed for paediatric use for the treatment of obsessive-compulsive disorder and one of them for the treatment of attention deficit / hyperactivity disorder.

It is recognised that a doctor may sometimes take a decision based on the individual clinical needs of a child or an adolescent to use these products for the treatment of depression or anxiety. The CHMP is recommending that in these cases patients be monitored carefully for the appearance of suicidal behaviour, self-harm or hostility, particularly at the beginning of treatment.

The CHMP also stresses the following:

  • Treatment should not be stopped by the patient or the parents without first seeking medical advice from the treating doctor, because there is a risk of experiencing withdrawal symptoms, such as dizziness, sleep problems and anxiety if discontinuation is abrupt.
  • When treatment is being stopped, it is recommended to gradually reduce the dose over several weeks or months.
  • Patients or parents who have any concerns about the medication are advised to consult the treating doctor at the next available opportunity to discuss treatment options and support.

Notes

  • The review looked at the medicines containing the following substances: atomoxetine, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacepran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine.
  • The review was initiated at the request of the European Commission on 17 December 2004. The legal basis for the review is Article 31 of the Community code on medicines for human use for all substances except duloxetine, for which the legal basis is Article 18 of Council Regulation (EEC) No 2309/93.

Key facts

Approved name
Serotonin-specific reuptake inhibitors and serotonin-noradrenaline reuptake inhibitors
International non-proprietary name (INN) or common name
atomoxetine, citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, venlafaxine
Class
Serotonin-specific reuptake inhibitors and serotonin-noradrenaline reuptake inhibitors
Reference number
CHMP/287837/05
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Status
European Commission final decision
Opinion date
21/04/2005
EC decision date
19/08/2005

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

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