Dinny McGinley (Donegal South West, Fine Gael)

Gabhaim buíochas leis an Seanadóir Norris as ucht an t-ábhar seo a ardú inniu. Perhaps the Senator might be good enough to convey my condolences and sympathy to the mother and family of the unfortunate young man to whom he referred.

Selective serotonin reuptake inhibitors, SSRIs, are anti-depressants available on prescription only. They are licensed for use in Ireland and across the European Union for the treatment of depressive disorders and some anxiety conditions. It is estimated that at any one time more than 450,000 people in Ireland experience depression. Young people, in particular, can find it hard to cope with depression and one in ten adolescents experience a depressive episode. Untreated depression can have a fatal outcome. Anti-depressants, when used properly, are effective in the treatment of depression and lead to a reduction in suicidal thoughts. According to the College of Psychiatry of Ireland, approximately 3% of Irish adults use anti-depressants. It is important to note that, in addition to the significant health benefits of medicines, all medicines carry some risks. People taking anti-depressant medicines may also experience adverse effects.

The Irish Medicines Board is responsible for the licensing and safety and monitoring of medicines in Ireland. In conjunction with medicines authorities in other member states, it continuously monitors the safety of medicines in a collaborative way and takes actions, as necessary, to ensure medicines continue to have a favourable benefit-risk profile for patients. As part of the system of monitoring medicines' safety, it has a spontaneous reporting system by which health care professionals and patients can report suspected adverse reactions to medicines. It also reviews, approves and continuously updates the product information and package leaflet of medicines to reflect the current state of knowledge of each medicine and the risks associated with its use. All new and emerging safety data are assessed by it in conjunction with EU medicines authorities.

Unfortunately, depression can be associated with an increased risk of suicidal thoughts, self-harm and suicide in some patients. This risk persists until significant remission of the depression occurs. It has been known for some time that there is a potential risk of suicide related behaviour, particularly in the early stages of treatment with anti-depressants. The approved product information for anti-depressants specifically highlights the need for careful monitoring of patients with suicidal thoughts following initiation of treatment.

In 2008 a comprehensive review of the safety profile of SSRIs was undertaken at European Union level by EU medicines authorities. During this safety review the existing warnings contained in SSRI product information were further strengthened throughout Europe and manufacturers of SSRIs were obliged to update the product information on all SSRIs. The new updated warnings were communicated by the Irish Medicines Board to health care professionals.

While anti-depressants play a central role in the treatment of depression, patient safety must be paramount. The Irish Medicines Board actively monitors the safety of medicines, including SSRIs, on an ongoing basis and does not hesitate to issue safety warnings and update information, if required. At European level, new legislation will be implemented later this year which will include a range of new measures to improve patient safety such as improved systems for monitoring the safety of medicines and patient reporting of adverse reactions. The purpose of the legislation is to ensure the system of monitoring medicines safety in Ireland and throughout the European Union is as responsive as possible to the emergence of new information on medicines safety in order that patients continue to have access to safe and effective medicines.