The Pharmaceutical Journal
Vol 271 No 7279 p803
13 December 2003

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Medicines and Healthcare products Regulatory Agency (www.mhra.gov.uk)

Antidepressant warning extended to other SSRIs

A government warning not to use paroxetine or venlafaxine (Efexor) to treat depression in children has been extended to include sertraline (Lustral), citalopram (Cipramil), escitalopram (Cipralex) and fluvoxamine. The only selective serotonin reuptake inhibitor not to be included in the warning is fluoxetine.

The Medicines and Healthcare products Regulatory Agency issued advice to health care professionals earlier this year (PJ, 14 June, p813 and 27 September, p395) after trial data indicated that use of paroxetine and venlafaxine in children and adolescents was associated with an increased risk of suicidal behaviour.

The data sparked a review of the evidence relating to other antidepressants by the Committee on Safety of Medicines. The CSM has now completed its review and advises that in patients with major depressive disorder who are under 18 years:

• These products should not be prescribed as new therapy
• Completion of planned treatment should be considered in patients sucessfully treated with any of these products
• Change of treatment should be considered for patients not doing well

The CSM points out that fluoxetine is not licensed for the treatment of major depressive disorder in those under 18 years but acknowledges that the balance of risks and benefits is favourable (www.mhra.gov.uk).