Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
Link to this: Individually | In context

Question 649: To ask the Minister for Health and Children if her attention has been drawn to reports that certain medications, in particular some anti-depressants, may increase the risk of suicidal thoughts or behaviours; her views on whether this risk is adequately highlighted in the information packets of these medications; if further legislation is needed in this area; and if she will make a statement on the matter. [1031/07]

Mary Harney (Dublin Mid West, Progressive Democrats)
Link to this: Individually | In context

I am aware of concerns that have been raised in recent years concerning the safety of the class of medicines known as Selective Serotonin Reuptake Inhibitors (SSRIs) which are used to treat depression.

The Irish Medicines Board is the statutory body responsible for the regulation of medicinal products in Ireland. The Board, in consultation with its European counterparts, has continuously monitored the safety of this class of medicines since they were first licensed for the Irish market. The Board has taken regulatory action on these products when deemed necessary.

In 2004 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. 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.

The documentation used for these products includes special warnings and precautions for use, particularly in relation to the need for close monitoring of patients using these products who may be at risk of suicidal behaviour.

The Board and its European counterparts will continue to actively monitor the safety of all medicinal products licensed for use in Ireland, evaluate all new scientific data that emerges and take any regulatory action deemed appropriate.