Dáil Éireann Debate, Wednesday - 30 June 2004
247 Ms McManus asked the Minister for Health and Children his views regarding the continued use of SSRIs and a drug (details supplied) in view of recent reports of the adverse effects caused by these drugs; and if he will make a statement on the matter. [19634/04]
View answerThe 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 reuptake inhibitors, SSRIs, since they were first licensed for the Irish market. The board has taken regulatory action on these 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 and which includes Seroxat. This review was undertaken on the basis of safety concerns relating to these products. The board actively participated in this review, which involved a complete benefit/risk re-assessment, and concluded that the benefit/risk profile of products containing paroxetine remains positive. A number of recommendations were made for inclusion on the product's licence documents, the purpose of which was to harmonise the information on these products across member states. The majority of these recommendations are already reflected on the licence documentation currently approved in Ireland. This documentation includes special warnings and precautions for use, particularly about the need for close monitoring of patients using medicinal products containing paroxetine.
The board will continue to actively 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.
