Use of anti-depressant banned

[Guest guest]

http://www.info.doh.gov.uk/doh/intpress.nsf/page/2003-0505?OpenDocument

Down on Antidepressants? Last week, the British Medicines and Healthcare

Products Regulatory Agency (MHRA) banned use by children of most of the

most-commonly proscribed type of anti-depressant drugs, those known as selective

serotonin reuptake inhibitors (SSRIs). This followed a Department of Health

study

concluding that, with the exception of Prozac, the risks of SSRIS for children

outweigh benefits

Press release: reference 2003/0505

Last 7 days | Archive | Search | News Desk | Help

Wednesday 10th December 2003

SAFETY REVIEW OF ANTIDEPRESSANTS USED BY CHILDREN COMPLETED

ADVISORY: IT IS ESSENTIAL THAT PATIENTS TAKING SSRIs DO NOT SUDDENLY

DISCONTINUE USE OF THE DRUG. ANY CHANGES MUST TAKE PLACE UNDER MEDICAL

SUPERVISION.

PLEASE REFLECT THIS POSITION IN REPORTS

The majority of SSRIs (selective serotonin reuptake inhibitors) - the most

commonly prescribed type of anti-depressants - are not suitable to be used by

under 18s, said Alasdair Breckenridge, Chair of the Medicines and Healthcare

products Regulatory Agency.

The new advice follows a review by a group of medical experts set up earlier

this year to look at the safety of SSRIs (selective serotonin reuptake

inhibitors). The group has now studied all available evidence and has found that

risks of treating depressive illness in under 18's with certain SSRIs outweigh

the

benefits of treatment.

There is no, or insufficient, evidence from clinical trials that benefits

outweigh the risks of side effects for sertraline (Lustral), citalopram

(Cipramil), escitalopram (Cipralex) and fluvoxamine (Faverin). Fluoxetine, or

Prozac,

appears to have a positive balance of risks and benefits in the treatment of

depressive illness in the under 18s.

An estimated 30 - 40,000 thousand children and teenagers are prescribed

SSRI's across the UK, about half of those were treated with fluoxetine (Prozac).

In

June, a warning was issued about the use of paroxetine (Seroxat) in children

under the age of 18, and further advice was given in September about the use

of venflaxine (Efexor). Today's advice completes the picture on the remaining

five SSRIs.

Professor Gordon Duff, Chairman of the Committee on Safety of Medicines,

said:

" The CSM Expert Group has delivered comprehensive advice on the use of these

drugs in children and young people following a thorough review of all the

evidence available. This gives parents, young people and those who treat these

devastating illnesses the information they need to make informed decisions about

treatment. "

" Like Seroxat and Efexor, none of these drugs has ever been licensed for use

in those under 18.

" We know, however, they are used in this age group outside of their licensed

indications where prescribers make a judgement on their own responsibility

that it is the correct treatment for a particular patient.

" It is therefore important that patients, parents and doctors are aware of

the new advice. Young people with depressive illness currently taking any

SSRI other than fluoxetine should not stop taking their medicine but should

consult their doctor for advice on treatment " .

In a new step, data from the clinical trials on SSRIs and children, supplied

by the drug companies to the Expert Group, is also being released today to

allow clinicians to assess the information on which the new advice is based.

The Expert Group is now focusing on the ongoing review of the efficacy and

safety of SSRIs in adults, and this should be completed in the first half of

next year.

Professor Ian Weller, Chairman of the Working Group, said:

" We are now working on completing the review of the safety of these medicines

in adults. This is one of the most comprehensive reviews of a class of

medicines ever to be undertaken and it is painstaking work, examining evidence

from

literally hundreds of clinical trials but we are determined to see this

important work through. It should be complete in the Spring. In the meantime,

there

is no evidence to suggest that the risks of treatment outweigh the benefits in

adults. Patients who are experiencing any side effects or are concerned about

their treatment should discuss these with their doctor " .

Notes to editors

1. The SSRIs for which the CSM Expert Group have judged the balance of risks

and benefits to be negative or on which there is too little evidence to make a

decision are sertraline (tradename Lustral), citalopram (tradename Cipramil),

escitalopram (tradename Cipralex), fluvoxamine (tradename Faverin),

paroxetine (tradename Seroxat) and venflaxine (tradename Efexor).

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. In April 2003, the CSM established an Expert Working Group to consider the

safety of Selective Serotonin Reuptake Inhibitors (SSRIs), used for the

treatment of depressive illness and anxiety disorders since the late 1980s. The

Group incorporates specialist experts in the clinical management of depressive

illness in childhood and adolescence.

4. Regulatory action to amend the marketing authorisations for all the

products has been initiated by the MHRA and will be carried through as a matter

of

urgency.

5. Prescribing advice and clinical trials data is available on

www.mhra.gov.uk