Selective Serotonin Reuptake Inhibitors, (SSRIs) Usage in Children

Notice type: Warning

Date: 10/12/2003

 

Product name or type:
citalopram (Cipramil), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Faverin), paroxetine (Seroxat), sertraline (Lustral) and venlafaxine (Efexor)


Product Classification:
SSRIs


Target Audience:
Healthcare Professionals and Patients


Problem Or Issue:
The Irish Medicines Board today confirmed that Selective Serotonin Reuptake Inhibitors, (SSRIs) are not and have never been licensed for use in children (under 18 yrs) in the treatment of Major Depressive Disorder (MDD) in Ireland

The IMB is fully aware of the review undertaken by the UK expert group, details of which were announced today and wishes to re-emphasise that SSRIs are not recommended for use in the treatment of MDD in children in Ireland, as the risks of treatment with certain SSRIs are considered to outweigh the benefits of treatment in this condition. 

Dr. Joan Gilvarry, Director of Human Medicines, IMB stated that although SSRIs are not licensed for children in Ireland, doctors can prescribe them for patients under their care if it is deemed appropriate. “We strongly recommend that patients taking SSRIs do not suddenly discontinue use of the drug, because of the risk of withdrawal effects. Any changes must take place under medical supervision.” 

The SSRIs and related antidepressants that are licensed in Ireland for use in adults include citalopram (Cipramil), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Faverin), paroxetine (Seroxat), sertraline (Lustral) and venlafaxine (Efexor). It should be noted that sertraline (Lustral) and fluvoxamine (Faverin) are licensed for the treatment of Obsessive Compulsive Disorder (OCD) in children and adolescents as the balance of risks versus benefit has been shown to be positive in this condition. 

The findings of clinical trial research into the effect of SSRIs in children are not considered to have any impact for the use of SSRIs in adult patients. The IMB will continue to monitor the quality, safety and efficacy of SSRIs and initiate any further regulatory action deemed necessary.


Background Information Or Related Documents:
Selective Serotonin Reuptake Inhibitors, (SSRIs) Usage in Children Document


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