Report of the Committee on Safety of Medicines Expert Working Group on the Safety of Selective Serotonin Reuptake Inhibitor Antidepressants

著者

    • Great Britain. Expert Working Group on the Safety of Selective Serotonin Reuptake Inhibitor Antidepressants

書誌事項

Report of the Committee on Safety of Medicines Expert Working Group on the Safety of Selective Serotonin Reuptake Inhibitor Antidepressants

TSO, 2005

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注記

Includes bibliographical references

"December 2004"

内容説明・目次

内容説明

This is the final report of the Committee on Safety of Medicines Expert Working Group, established in May 2003 to investigate ongoing safety concerns about the use of Selective Serotonin Reuptake Inhibitors (SSRIs) for the treatment of depressive illness and anxiety disorders, particularly relating to suicidal behaviour and withdrawl reactions. The report reviews available data on these medicines and issues discussed include: the regulatory background; depressive illness and self-harm; pharmacovigilance and data sources; pharmacology of SSRIs and related antidepressants; safety and efficacy in children and adolescents with major depressive disorders; suicidal behaviour, withdrawl reactions and drug dependence; dose response; the patient experience; and further research requirements. Findings include that, on the balance of risks and benefits, fluoxetine (Prozac) is judged to be effective for the treatment of depressive illness in the under-18s; there is epidemiological evidence that the risk of self-harm in depressed patients is greatest around the time of presentation to medical services, and the risk of suicide may increase in the early stages of treatment; there is no clear evidence of an increased risk of self-harm or suicidal behaviour when SSRIs are discontinued; and patients should be monitored around the time of dose changes for any changed symptoms.

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