Shown: posts 1 to 7 of 7. This is the beginning of the thread.
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.
++++++++++++++++++++++++++++++++
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
Posted by pixygoth on September 22, 2003, at 9:19:02
In reply to Effexor Use in Children under 18 - UK Guidelines, posted by NikkiT2 on September 22, 2003, at 6:41:10
What's the story though with the idea that one's biochemistry changes as you hit 18??? I started the stuff just after I turned 18 - does that make it safe for me?? Good **** I'm angry about this stuff, specially since I was reluctant to start ADs at all... and the doc pushed them... See also the woman above with the 15y.o. on Effexor... aaarghh!!
Posted by Bill LL on September 22, 2003, at 10:26:56
In reply to Effexor Use in Children under 18 - UK Guidelines, posted by NikkiT2 on September 22, 2003, at 6:41:10
Thanks for the post!
I think that the conclusion from the study is that Effexor might not be the best choice as the FIRST drug to try for children. Although the increase in hostility and suicidal ideation was very small (only 2%), I would probably recommend an SSRI as a first try for kids.
However, if SSRI's and other drugs are tried first and the child does not get better, it would be irresponsible not to try Effexor. Effexor has been shown to be extremely safe and effective in many many people.
I would guess that untreated depression in children is approximately a million times more dangerous than Effexor.
Posted by pixygoth on September 22, 2003, at 12:18:20
In reply to Re: Effexor Use in Children under 18 - UK Guidelines, posted by Bill LL on September 22, 2003, at 10:26:56
Bill LL -
don't you think that children of all people should be treated as barometers of society rather than ill people? I can't get why so many of us (young people) are so miserable all at the moment unless it's environmental in some way. It's also spread wide geographically, right? So I'd say it's our INTELLECTUAL atmosphere that's poisoning our moods. (Neo-liberalism as the 'norm', etc.) What do you think?
And doesn't the survey result say that however small the difference was, the difference Venlafaxine made was that it made people MORE ill than the placebo did? That doesn't sound like effective phamacology at all.
S
Posted by Bill LL on September 22, 2003, at 12:57:05
In reply to Re: Effexor Use in Children under 18 - UK Guidelines, posted by pixygoth on September 22, 2003, at 12:18:20
I agree with what you are saying in terms of statistics, that 2% is a difference on the average. But for treating individual people, it's important to keep in mind that:
1) Effexor works extremely well for many people, and
2) Being depressed is a horrible condition.So the conclusion that I would come to is to try SSRI's first, and if that and other drugs don't work, it's better to try Effexor than to just give up and let a child remain depressed.
You have a good point about barometers of society, liberalism and so forth. I think that the lowering of morals in society contributes to depression. But I also think that many, if not most, people who are clinically depressed have a chemical imbalance that they were born with and that probably gets worse as they get older.
I think that natural selection has not reduced depression because depression does not generally cause death before child bearing years. Since 1989, when Prozac and other safe and effective drugs began to be available, people with depression have been "coming out of the closet" so it just appears that more people are now depressed.
> Bill LL -
> don't you think that children of all people should be treated as barometers of society rather than ill people? I can't get why so many of us (young people) are so miserable all at the moment unless it's environmental in some way. It's also spread wide geographically, right? So I'd say it's our INTELLECTUAL atmosphere that's poisoning our moods. (Neo-liberalism as the 'norm', etc.) What do you think?
> And doesn't the survey result say that however small the difference was, the difference Venlafaxine made was that it made people MORE ill than the placebo did? That doesn't sound like effective phamacology at all.
> S
Posted by loolot on September 22, 2003, at 14:57:16
In reply to Re: Effexor Use in Children under 18 - UK Guidelines, posted by pixygoth on September 22, 2003, at 12:18:20
> So I'd say it's our INTELLECTUAL atmosphere that's poisoning our moods. (Neo-liberalism as the 'norm', etc.) What do you think?
>
How about neo conservatism? War mongering, all of our rights given over to corporate interests, mediated existence,etc. This seems more damaging than any liberal agenda. JMO
Posted by Dr. Bob on September 23, 2003, at 0:03:56
In reply to Re: Effexor Use in Children under 18 - UK Guidelin, posted by loolot on September 22, 2003, at 14:57:16
> How about neo conservatism? War mongering, all of our rights given over to corporate interests, mediated existence,etc. This seems more damaging than any liberal agenda. JMO
I'd like follow-ups regarding conservative and liberal agendas to be redirected to Psycho-Social-Babble, thanks.
Bob
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