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Executive summary: Context Selective Serotonin Reuptake Inhibitors (SSRIs) and related antidepressants have been used in the treatment of depressive illness and anxiety disorders since the late 1980s. The safety of SSRIs has been under close review by the Medicines and Healthcare products Regulatory Agency (MHRA) since the products were first marketed. Background In May 2003, in response to continuing public concerns about the safety of SSRIs, an Expert Working Group of the Committee on Safety of Medicines (CSM) was convened to investigate ongoing safety concerns with these medicines, in particular around suicidal behaviour and withdrawal reactions/dependence. The Expert Working Group has studied all the available data including that from published and unpublished clinical trials, spontaneous reporting data from health professionals and patients, evidence from key stakeholders and data from the General Practice Research Database (GPRD). This included a study commissioned by the MHRA. Output of the Working Group The work of the Group resulted in CSM advice on the use of SSRIs in the paediatric population, advice to the European review of paroxetine, conclusions on the key issues relating to adult use which are general to all the medicines included in the review, and regulatory action in relation to particular medicines. This is the final report of the Group.

Type

Report

Publisher

MHRA

Publication Date

2005