Antidepressant Medication for Children

Notice type: 3rd Party Publications

Date: 30/11/2005


Product name or type:
Antidepressant Medication for Children - MIMS

MIMS Publication November 2005

Active Substance:
Citalopram;Escitalopram; Fluoxetine; Fluvoxamine; Mianserin;Mirtazapine; Paroxetine;Reboxetine; Sertraline;Venlafaxine

Prescription Required:

Problem Or Issue:
Antidepressant Medication for Children


The safety of antidepressants, particularly substances belonging to the groups of selective serotonin re-uptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), has again been reviewed and evaluated by the IMB, together with its expert committees and EU counterparts. 

A formal European-wide re-evaluation of the above medicinal products and their use in the paediatric/adolescent populations was initiated in December 2004, following a Referral to the Committee for Human Medicinal Products (CHMP). This particular Referral was undertaken because of safety concerns regarding an increased risk of suicide-related behaviours in these groups of patients. 

Outcome of Review 

The data reviewed included information from placebocontrolled randomised clinical trials, literature reviews (i.e. results of randomised clinical trials, observational studies and epidemiological studies). Most of the trials included patients with major depressive disorders (MDD), while a few included patients with various anxiety disorders, i.e. Obsessive Compulsive Disorder (OCD). None of the products concerned is authorised (i.e. licensed) in Ireland for the treatment of depression in children and adolescents. However, sertraline and fluvoxamine are authorised for OCD in these groups of patients. 

From its review of the data, the CHMP concluded that there is a potential signal of an increase in suicidal behaviours, including suicide attempts and suicidal ideation and/or related behaviours such as self-harm, hostility and mood lability in children treated with SSRIs and SNRIs. This signal was present in all products for which study data were available, and from the available evidence it was considered that this signal may be class-related. There were no reports of suicide associated deaths in children and adolescents in any of the clinical trials. It was recommended that appropriate warning statements should be added to the product information for all relevant products. 

The European Commission recently accepted the recommendations from the CHMP and the associated changes to the product information, outlined below. 

Revised Product Information 

Changes to the product information include the following: 

• A warning to remind prescribers that SSRIs/SNRIs should not be used in children and adolescents under 18 years of age. 

• A statement advising that if, based on clinical need, a decision to treat is taken, patients should be carefully monitored for the appearance of suicidal symptoms. 

• A statement indicating that data from controlled clinical trials have shown an increased risk of suicide-related behaviours (suicide attempt and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour and anger). 

• A statement indicating that long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development have not been demonstrated. 

These changes are currently being implemented in the product information for all relevant products authorised for use in Ireland. 

Prescribers are requested to notify the IMB of any suspected cases of suicidal behaviour, self-harm or hostility occurring in children and adolescents associated with use of antidepressant treatment.

Background Information Or Related Documents:
Antidepressant Medication for Children Document

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