Fwd: [SSRI-Research] UK GOVERNMENT PAPER 10.03.2003 SEROXAT (Paxil) NOT TO BE USED FOR CHILDREN...

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[sSRI-Research] UK GOVERNMENT PAPER 10.03.2003 SEROXAT (Paxil) NOT TO

BE USED FOR CHILDREN...

 

UK GOVERNMENT PAPER 10.03.2003 SEROXAT NOT TO BE

USED FOR CHILDREN...

Tue, Jun 10 2003 at 6:19 am

 

http://www.info.doh.gov.uk/doh/intpress.nsf/page/2003-0223?Op

enDocument

 

Tuesday 10th June 2003

 

SEROXAT MUST NOT BE USED FOR TREATMENT OF

CHILDREN WITH DEPRESSION

ADVISORY: IT IS ESSENTIAL THAT PATIENTS TAKING

SEROXAT DO NOT SUDDENLY DISCONTINUE USE OF THE

DRUG. ANY CHANGES MUST TAKE PLACE UNDER MEDICAL

SUPERVISION. PLEASE REFLECT THIS POSITION IN

REPORTS

 

 

New expert advice recommends that the drug Seroxat

(paroxetine) is not used to treat children and teenagers under

the age of 18 years, for depressive illness, said Professor

Alasdair Breckenridge, Chairman of the Medicines and

Healthcare products Regulatory Agency.

 

New data, received within the last two weeks, has been

evaluated and considered by the Committee on Safety of

Medicines, (CSM) and its Expert Working Group on SSRIs. It

shows that there is an increase in the rate of self harm and

potentially suicidal behaviour in this age group, when Seroxat is

used for depressive illness. It has become clear that the benefits

of Seroxat in children for the treatment of depressive illness do

not outweigh these risks.

 

Seroxat was first licensed in the UK in 1990 for the treatment of

depression. In the last year, approximately 4 million

prescriptions were issued and an estimated 8,000 patients

under 18 years were treated wih Seroxat. It is estimated that

almost 17 million people worldwide have been treated with

Seroxat since it was first licensed.

 

The Chairman of CSM, Professor Gordon Duff, said:

 

" SSRIs are an important group of medicines, which help patients

who suffer from depression, anxiety, panic disorder and

obsessive compulsive disorder. These serious conditions can

cause severe suffering and the availability of effective treatments

is essential.

 

" Seroxat is not licensed for use in children but we know it is used

in this age group outside its licensed indications where

prescribers make a judgement on their own responsibility that it

is the right treatment for a particular patient. It is therefore

important that doctors, patients and parents are aware of the

new advice. Young people under 18 years currently taking

Seroxat for depression should consult their doctor. "

 

The Chairman of the Expert Group looking at SSRIs, Professor

Ian Weller

said:

 

" The expert group will be examining urgently what implications, if

any, these new findings have for the use of Seroxat in adults.

CSM has advised that at present the evidence is not sufficient to

confirm a causal association between SSRIs and suicidal

behaviour in adults. The benefits of taking Seroxat are well

established and patients over 18 years and those who are

benefiting from Seroxat should not be frightened into stopping

their medication. Young people under 18 years currently taking

Seroxat for depressive illness should consult their doctor for

advice. "

 

Richard Brook, Chairman from the mental health charity, MIND

said:

 

" MIND has been concerned to ensure that the experiences of

users of Seroxat were taken seriously. This new evidence

underlines the concerns that young patients have been voicing

and MIND accept that speedy action has been taken to address

this new evidence. MIND strongly believes that the decision

today requires us to move very quickly forward on the review of

Seroxat and other SSRIs especially given the strength of concern

we've heard from people taking these drugs. "

 

Prescribing information has been cascaded via message to

health care professionals through the Chief Medical Officers

Public Health Link; advice to prescribers and patients is also be

available on the MHRA website.

 

The recent concerns expressed by patient groups and in the

media over the safety of Seroxat have been taken very seriously.

In response to concerns of the association of Seroxat with

withdrawal reactions and also suicidal behaviour, a new expert

working group of the Committee on Safety of Medicines has

been set up to further review the safety of SSRIs and to ensure

the advice in the product information for both patients and

prescribers is optimal for the safe use of these products.

 

The number of NHS Direct is 0845 4647.

 

Notes to editors

 

1. Seroxat is the tradename for the medicine paroxetine, which

has been used successfully to treat depressive illness in

millions of people worldwide over the last decade. It is a

member of a group of medicines known as Selective Serotonin

Reuptake Inhibitors (SSRIs). These drugs work by increasing

the level of the chemical serotonin in the brain, which helps to

alleviate the symptoms of depression. Seroxat has also been

shown to help patients who suffer with Anxiety, Post-Traumatic

Stress Disorder, Social Anxiety, Panic disorder and Obsessive

Compulsive Disorder.

 

2. The CSM is an independent Committee of scientific experts

that advise Government on the safety, quality and effectiveness

of medicines, including vaccines. It is also responsible for

promoting the collection and investigation of reports on

suspected adverse reactions to medicines already on the

market. The MHRA is the executive arm of the UK's Drug

Licensing Authority and is responsible for all aspects of the

regulation of medicines in the UK.

 

3. Prescribers advice is on the MHRA website: www.mhra.gov.uk

 

 

 

 

 

 

 

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