WHO Pharmaceuticals Newsletter 2003, No. 05
(2003; 15 pages) View the PDF document
Table of Contents
Open this folder and view contentsREGULATORY MATTERS
Close this folderSAFETY OF MEDICINES
View the documentROFECOXIB/ CELECOXIB - GI adverse effects
View the documentHRT - CPMP to re-evaluate risk-benefit
View the documentLEVETIRACETAM & LOPINAVIR/ RITONAVIR - Potential for dispensing errors
View the documentMEFLOQUINE HYDROCHLORIDE - Issuance of medication guide for travellers
View the documentREPAGLINIDE & GEMFIBROZIL - Risk of hypoglycaemia with concomitant use
View the documentSALMETEROL - New safety information for use in asthma
View the documentSELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIs) - Adverse effects in neonates
View the documentVENLAFAXINE - Unfavourable risk/ benefit ratio for use in children and adolescents
Open this folder and view contentsDRUGS OF INTEREST
Open this folder and view contentsFEATURE
Open this folder and view contentsMISCELLANY
 

VENLAFAXINE - Unfavourable risk/ benefit ratio for use in children and adolescents

UK, USA, Canada, Sweden. The Expert Working Group of the Committee on Safety of Medicines (CSM) has advised that venlafaxine should not be used in children under the age of 18 years for the treatment of depressive illness since the balance of risks and benefits of this drug venlafaxine is unfavourable in this population. New results from clinical trials do not demonstrate the efficacy of venlafaxine in depressive illness in children between the age of 6 -17 years; the data show an increase in the harmful outcomes including hostility, suicidal ideation and self-harm in the venlafaxine (Efexor, Efexor XL) group compared with the placebo group. The efficacy and safety of venlafaxine for other indications in this age group have not yet been established. However, venlafaxine should not be stopped abruptly but the dose gradually reduced over two weeks to minimise the risk of withdrawal reactions.

Wyeth Pharmaceuticals has issued a ‘Dear Healthcare Professional’ letter, both in the US and in Canada for the above safety and prescribing information.

The Swedish Medical Products Agency notes that the risk benefit ratio of venlafaxine in adolescents is being evaluated on the EU level and that the agency will hold a workshop in 2004 to come up with recommendations for the treatment of depression; the agency requests those prescribing venlafaxine to be alert to suicidal thoughts in children and points out that venlafaxine is not approved for use in this age group.

References:

1. Message from Professor G Duff, Chairman, Committee on Safety of Medicines, 19 Sept 2003.
Available from URL:
http://medicines.mhra.gov.uk/

2. ‘Dear Healthcare Professional’ letter from Wyeth Pharmaceuticals, 10 Sept 2003.
Available from URL:
http://www.hc-sc.gc.ca

3. ‘Dear Healthcare Professional’ letter from Wyeth Pharmaceuticals, 22 Aug 2003.
Available from URL:
http://www.fda.gov

4. Scrip World Pharmaceutical News No. 2887, 24 Sept 2003.

 

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