Dáil Éireann Debate, Tuesday - 15 June 2004
347 Mr. J. O’Keeffe asked the Minister for Health and Children if his attention has been drawn to concerns regarding the use of a new class of anti-depressants known as SSRIs; his views on whether warnings should be issued regarding their dangers; and if he will make a statement on the matter. [17170/04]
Amharc ar fhreagraThe Irish Medicines Board is the statutory body responsible for the regulation of medicinal products in Ireland.
The board, in consultation with its European colleagues, has continuously monitored the safety of the class of medicines known as selective serotonin re-uptake inhibitors, or SSRIs, since they were first licensed for the Irish market. The board has taken regulatory action on those products when deemed necessary.
Most recently, the board took part in a Europe-wide review of medicinal products containing paroxetine, which is one of the group of SSRIs which is used to treat mild to moderate depression. That review was undertaken on the basis of safety concerns relating to those products. The board actively participated in that review, which involved a complete benefit-risk re-assessment, and concluded that the benefit-risk profile of products containing paroxetine remains positive. Several recommendations were made for inclusion on the product's licence documents, the purpose of which was to harmonise the information on those products across member states. I am informed that the majority of those recommendations are already reflected on the licence documentation currently approved in Ireland. That documentation includes special warnings and precautions for use, particularly regarding the need for close monitoring of patients using medicinal products containing paroxetine.
The board will continue actively to monitor the safety of all medicinal products licensed for use in Ireland, evaluate all new scientific data that emerge and take any regulatory action deemed appropriate.
