Press release: reference 2003/0223

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

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