Clare Daly (Dublin Fingal, Independent)
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304. To ask the Minister for Health if his attention has been drawn to the increased risk of violence and suicide among young persons under 25 years of age using SSRI anti depressants; the studies that he has requested to be carried out into this drug; if he has given consideration to attaching a black box warning to this class of drugs; and if he will make a statement on the matter. [33259/17]

Simon Harris (Wicklow, Fine Gael)
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Selective serotonin reuptake inhibitors (SSRIs) are a group of anti-depressant medications available through prescription only and are authorised for use in Ireland and across the EU for the treatment of depressive disorders and some anxiety related conditions. Some of these medications are also authorised for use in children and adolescents aged 8 to 18 years for the treatment of moderate to severe major depressive episodes if the depression is unresponsive to psychological therapy.

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 when a patient starts to take an anti-depressant until significant remission of their depression occurs.

Across the EU, the product information documents (the Summary of Product Characteristics (‘SmPC’) and the Package Leaflet (‘PL)) are the main documents for communication of information and advice regarding a medicine. The format and content of these documents is laid down in legislation and regulatory guidance documents. The SmPC and PL are reviewed and approved as an intrinsic part of the licensing of a medicine. They are continuously updated for all medicines, to reflect the current state of knowledge of the medicine and the risks associated with its use. As such, it is considered important for healthcare professionals and patients/carers to regularly read/review these documents to support safe and appropriate use. It is important to note too, that the information included in the US ‘black box’ is entirely consistent with that provided in the approved product information (SmPC and PL) for SSRIs in the EU.

The SmPC is mainly intended for use by healthcare professionals and includes detailed information on the use, dosing recommendations, precautions for use and the known side-effects of the medicine concerned. The Health Products Regulatory Authority (HPRA) is the competent authority for the regulation of medicines in Ireland. SmPCs for products currently authorised in Ireland are accessible from the HPRA website (). The PL reflects the more comprehensive information described in the SmPC, but is required to be presented in an abbreviated and easy-to-read format and is subject to user-testing to ensure its ease of readability. Healthcare professionals and patients are advised of the risk of suicide associated with SSRIs through the product information for the individual SSRI medicines which specifically highlight the need for monitoring of the patient following initiation of therapy: 'as improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs'. The Package Leaflet accompanying these products advises that patients and their care-givers should be alerted about 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.

With respect to SSRIs used in children and adolescents aged 8 to 18 years with depression, the product information for SSRIs describes that treatment should be initiated and monitored under specialist supervision, with dose adjustments made carefully, on an individual basis, to maintain the patient at the most effective dose. For children who respond to treatment, the need for continued treatment after 6 months should be reviewed. If no clinical benefit is achieved within 9 weeks, treatment should be reconsidered.

The HPRA, in conjunction with European counterparts, continues to review the safety of authorised medicines and takes appropriate regulatory action when necessary, including product information updates through the applicable authorisation framework for the medicines concerned.

The HPRA emphasises the fact that all medicines have some risks and a small number of people may develop side effects (also known as adverse reactions). The decision to use a particular medicinal product for an individual patient rests with the healthcare professional treating the patient. The clinician balances the risks associated with a medicine in the context of the overall benefit of the medicine to the health of the patient and the condition being treated.