Dáil Éireann Debate, Tuesday - 7 December 2004
138 Ms McManus asked the Tánaiste and Minister for Health and Children if her attention has been drawn to the US Food and Drug Administration proposed medication guide regarding the use of antidepressants in children or teenagers; if she will consider proposing such guidelines here; and if she will make a statement on the matter. [32108/04]
View answerAs the competent authority for the regulation of medicinal products in Ireland, the Irish Medicines Board assesses the quality, safety and efficacy of medicinal products. The matter raised by the Deputy is one which falls within the IMB's remit. I understand that the IMB is aware of the ongoing discussions at the US Food and Drug Administration concerning the introduction of a proposed medication guide regarding the use of antidepressants in children and adolescents. I am advised that all authorised medicinal products in Ireland include product specific information which acts as guidance for both healthcare professionals and patients. However, in the US such product specific information is not always provided and medication guides have only been developed in the case of a limited number of products, where specific communication to health care professionals is considered necessary.
The prescribing of antidepressants for children and adolescents has been under continuous review at both national and EU level for some time, with national regulatory action taken in respect of individual products, as considered warranted by the level of evidence available, on a product specific basis. These actions were notified to healthcare professions by the relevant companies. In addition, a "frequently asked questions" document relating to paroxetine, Seroxat, was placed on the IMB's website in June 2003.
A formal EU referral procedure was initiated in respect of paroxetine-containing products earlier this year and the required scientific opinion from the committee on proprietary medicinal products has been forwarded to the European Commission. The Commission decision is currently awaited and will be legally binding on all EU member states and will include guidance on appropriate use in children and adolescents. An EU expert working group, on which the IMB and other national experts from the EU member states are actively participating, is reviewing overall medication issues relating to children and adolescents. It is expected that this review will also offer appropriate guidance which will be communicated to healthcare professionals when available.
