Posted by NikkiT2 on September 22, 2003, at 6:41:10
This article has been produced today.. and I thought it would be interesting for some of you. Not sure I'm meant to be passing it on.. but it seemed too important not to.
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To:
NHS Trusts - Medical Directors (England)
Primary Care Trusts - Directors of Public Health
Primary Care Trusts - Medical Directors
Public Health LinkCc (Groups):
Chairman - Professional Executive Committee of PCT
DHSC - Directors of Public Health
Strategic Health Authorities (England) - Directors of Public Health
Territorial CMOsFax To:
From:
Professor Gordon Duff - Chairman of Committee on Safety of MedicinesDate:
19/09/03
Reference
CEM/CMO/2003/14Category:
IMMEDIATE (cascade within 6 hours)
Title:
SAFETY OF VENLAFAXINE IN CHILDREN AND ADOLESCENTS UNDER 18 YEARS IN THE TREATMENT OF DEPRESSIVE ILLNESS
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Broadcast Content:
PUBLIC HEALTH LINKTo: Directors of Public Health of PCTs to forward to:
- All GENERAL PRACTITIONERS - please ensure this message is seen by all practice nurses and non-principals working in your practice and retain a copy in your `locum information pack'.
- Deputising services
- Community paediatricians
- Project manager/Nurse lead in Walk in Centres
- Lead nurses in PCTs to forward to community nurses in childrens health
- Leads at nurse-led PMS Pilots
- PCT pharmaceutical advisers to forward to community pharmacists
- PCT Prescribing AdvisersMedical Directors of NHS Trusts to forward to:
- Consultant Psychiatrists
- Consultant Paediatricians
- Nurse Executive Directors of NHS Trusts
- Trust chief pharmacists to forward to Medicines Information Pharmacists
Cc: - Regional Directors of Public Health
- Directors of Public Health of Strategic Health Authorities to forward to SHA pharmaceutical advisers
- UK CMOs
- Chairmen of Professional Executive CommitteeDear Colleague
SAFETY OF VENLAFAXINE IN CHILDREN AND ADOLESCENTS UNDER 18 YEARS IN THE TREATMENT OF DEPRESSIVE ILLNESS
New results from clinical trials in children and adolescents have been reviewed by the Committee on Safety of Medicines (CSM) Expert Working Group on selective serotonin re-uptake inhibitors (SSRIs). The trials did not demonstrate efficacy in depressive illness in this age group (6-17 years) and showed an increase in the rate of harmful outcomes including hostility, suicidal ideation and self-harm in the venlafaxine (Efexor, Efexor XL) group compared with the placebo group. In the MDD (major depressive disorder) trials, the most common adverse events leading to discontinuation in at least 1% of children and adolescents treated with venlafaxine, and at a rate twice that of placebo, were as follows (percentages listed for venlafaxine and placebo respectively): hostility (2%, <1%) and suicidal ideation (2%, 0%). In addition, there were three suicide attempts in the venlafaxine group, compared with none in the placebo group. There were no suicides. Other adverse events occurring more commonly in the venlafaxine group were abdominal pain, loss of appetite and weight loss.
On the basis of these findings, the CSM's Expert Working Group has advised that the balance of risks and benefits of venlafaxine is unfavourable for the treatment of depressive illness in this age group. The Expert Working Group has advised that venlafaxine should not be used in children and adolescents under the age of 18 years for the treatment of depressive illness. The efficacy and safety of venlafaxine for other indications in children and adolescents under the age of 18 years have not yet been established.
When stopping treatment with venlafaxine
Venlafaxine should not be stopped suddenly because of the risk of withdrawal reactions. The dose should be gradually reduced over at least two weeks and the patient monitored in order to minimise the risk of withdrawal reactions. The period for discontinuation may depend on the dose, duration of therapy and the individual patient. If the dose is not tapered, there is a greater chance of experiencing side effects on withdrawal. Until further advice is issued, treatment of depressive illness in this age group should be as advised by a specialist.
The latest edition of Current Problems in Pharmacovigilance summarises the licensed indications of SSRIs and venlafaxine in children and adolescents. Further information on venlafaxine for prescribers and patients is available on the website of the Medicines and Healthcare products Regulatory Agency (MHRA) http://www.mhra.gov.uk. The company, Wyeth, will be issuing revised product information shortly. Should you require any additional information, please telephone xxxxx at the MHRA. Please report any suspected adverse reactions to venlafaxine via the Yellow Card reporting scheme to the CSM/MHRA.
Professor Gordon Duff
Chairman – Committee on Safety of Medicines
poster:NikkiT2
thread:262352
URL: http://www.dr-bob.org/babble/20030917/msgs/262352.html