Review of Selective Serotonin Reuptake Inhibitors (SSRI) Medicines

Notice type: Advisory

Date: 06/12/2004


Product name or type:
Selective Serotonin Reuptake Inhibitors (SSRI) Medicines

Product Classification:
Selective Serotonin Reuptake Inhibitors (SSRI) Medicines

Problem Or Issue:
The Irish Medicines Board today stated that it is continuing to actively participate in the ongoing European review of SSRIs and related antidepressants. The IMB considers that the current advice provided for these medicines is appropriate and their benefit/risk profile remains positive. The IMB will await the outcome of the EU review before implementing any further changes that may be recommended to update the product information for this group of medicines. 

The IMB states that this group of medicines has received extensive scrutiny at national and EU level and that their use in the treatment of depression and other conditions are considered to be beneficial for patients when appropriate healthcare intervention is applied through patient diagnosis and patient monitoring. The IMB and national experts have reviewed the outcome of the UK’s review on SSRIs issued today, and considers it appropriate to await the conclusions of the European expert review before taking any further regulatory action. 

The Irish product information for SSRIs and related antidepressants, already includes information for healthcare professionals and patients regarding the need for dosage control and safety monitoring. The IMB notes the UK’s recommendations for Venlafaxine (Efexor). The Irish product information currently includes advice for prescribing and monitoring of patients including those with cardiovascular disease. 

The IMB considers all new data and information in relation to medicinal products and monitors the safety of all authorised medicinal products on an ongoing basis. It participates in pan European evaluations of medicines through its membership of the European Medicines Agency (EMEA), which includes scientists and healthcare professionals from across Europe sharing information across a range of products. 

The IMB will continue to monitor these issues with national and EU colleagues, review any new data that becomes available and initiate regulatory action as appropriate.

Background Information Or Related Documents:
Review of Selective Serotonin Reuptake Inhibitors (SSRI) Medicines Document

Further Information:
For Information Contact:

Weber Shandwick FCC, Tel: 01 676 01 68 or 086 817 50 66

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