Children as young as eight may soon be able to use the antidepressant drug, Prozac, following a recommendation by the European Medicines Agency (EMEA).
Prozac (fluoxetine) is an SSRI (selective serotonin reuptake inhibitors). SSRIs are the most commonly prescribed class of antidepressant.
The drug is authorised for the treatment of major depressive episodes, obsessive compulsive disorder and bulimia nervosa. Currently in Ireland, its use is not recommended in children and adolescents under the age of 18.
However the European Medicines Agency has now said that Prozac should be considered in the treatment of children aged eight or older who suffer from moderate to severe depression and who do not respond to psychological therapy.
“The agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of using Prozac in this indication outweigh its potential risks, but that the marketing authorisation holder, Eli Lilly, should carry out additional studies to ensure that the safety profile of Prozac remains acceptable”, the agency said.
Based on the data reviewed, the CHMP concluded that the studies in children and adolescents showed ‘a positive effect’. However it recommended that Prozac should only be used together with psychological therapy in patients not responding to such therapy alone after four to six sessions.
If no clinical benefit is seen within nine weeks, ‘treatment should be reconsidered’. Meanwhile doctors and parents ‘should carefully monitor children and adolescents for suicidal behaviour, particularly at the beginning of treatment’.
A spokesperson for the Irish Medicines Board (IMB) confirmed that it had taken part in this review ‘and agreed with the conclusions’.
“The CHMP is the scientific committee of the EMEA. Ireland (through the IMB) and all member states have representation on this committee so that all views are considered”, the spokesperson told irishhealth.com.
The recommendation however ‘has to await approval by the EU Commission before it comes into effect’, the spokesperson added.