Eoghan Murphy (Dublin South East, Fine Gael)
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440. To ask the Minister for Health his views on the use of the anti-depressant selective serotonin re-uptake inhibitor; and if his attention has been drawn to studies that link it to increased cases of suicide and violence. [44306/14]

Kathleen Lynch (Cork North Central, Labour)
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Selective serotonin re-uptake inhibitors or SSRIs are anti-depressants available on prescription only. They are authorised for use in Ireland and across the EU for the treatment of depressive disorders and some anxiety related conditions.

Depression may be associated with an increased risk of suicidal thoughts, self-harm and suicide. This risk may persist, particularly in the early stages of treatment with anti-depressants such as the SSRIs when a patient starts treatment and until significant remission of their depression occurs. Healthcare professionals and patients are advised of this risk through the product information for the individual medicines which specifically highlight the need for monitoring of the patient following initiation of treatment. The approved product information accompanying these products advises that patients and their care-givers should be alerted to the need to monitor for any clinical worsening, suicidal behaviour or thoughts, or unusual changes in behaviour and to seek medical advice immediately if these symptoms appear.

The risk of suicide was reviewed at EU level on a number of occasions, most recently in 2008. During this safety review the existing warnings contained in the SSRI product information were further strengthened throughout Europe and manufacturers of SSRIs were obliged to update the product information on all SSRIs. The updated warnings were communicated by the Health Products Regulatory Authority (formerly known as the Irish Medicines Board) to doctors and pharmacists.

The Health Products Regulatory Authority (HPRA), in conjunction with medicines authorities in other member states continuously monitors the safety of medicines in a collaborative way and takes actions, as necessary, to ensure that medicines continue to have a favourable benefit-risk profile for patients. As part of the system of monitoring medicines safety, there is a spontaneous reporting system whereby healthcare professionals and patients can report suspected adverse reactions to medicines. The HPRA 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. New and emerging safety data is assessed in conjunction with EU medicines authorities.