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10/06/2003
Warning issued over prescribing seroxat to children
Patients under the age of 18 should not be prescribed the anti-depressant Seroxat (paroxetine), according to the Medicines and Healthcare products Regulatory Agency (MHRA).
According to the body, new data research shows that there is an increase in the rate of self-harm and potentially suicidal behaviour in children 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, the MHRA have said.
Seroxat was first licensed in the UK in 1990 for the treatment of depression, and in the last year, approximately 4 million prescriptions were issued and an estimated 8,000 patients under 18 were treated with Seroxat. It is estimated that almost 17 million people worldwide have been treated with Seroxat since it was first licensed.
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. The drug works 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.
The Chairman of Committee on Safety of Medicines, Professor Gordon Duff, said: "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."
Dr Alastair Benbow, Head of European Psychiatry for GlaxoSmithKline (GSK), the company which produces the drug, said that it would work with the UK government to implement the necessary changes.
However, he added that Seroxat had helped "millions of people around the world to lead fuller and more productive lives".
"Suicide is a well-recognised and all too often tragic outcome of depression, and is one of the most common causes of death among young people," Dr Benbow said.
"Depression is the most important cause of suicide, suicidal ideation and suicide attempts. There is no compelling evidence that Seroxat causes suicide and indeed, the adult clinical trial database does not demonstrate that Seroxat causes suicide, suicidal thinking or suicide attempts."
Dr Benbow said that in GSK's in-house trials, which included over 1,000 patients treated with paroxetine, not a single person committed suicide.
(GMcG)
According to the body, new data research shows that there is an increase in the rate of self-harm and potentially suicidal behaviour in children 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, the MHRA have said.
Seroxat was first licensed in the UK in 1990 for the treatment of depression, and in the last year, approximately 4 million prescriptions were issued and an estimated 8,000 patients under 18 were treated with Seroxat. It is estimated that almost 17 million people worldwide have been treated with Seroxat since it was first licensed.
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. The drug works 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.
The Chairman of Committee on Safety of Medicines, Professor Gordon Duff, said: "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."
Dr Alastair Benbow, Head of European Psychiatry for GlaxoSmithKline (GSK), the company which produces the drug, said that it would work with the UK government to implement the necessary changes.
However, he added that Seroxat had helped "millions of people around the world to lead fuller and more productive lives".
"Suicide is a well-recognised and all too often tragic outcome of depression, and is one of the most common causes of death among young people," Dr Benbow said.
"Depression is the most important cause of suicide, suicidal ideation and suicide attempts. There is no compelling evidence that Seroxat causes suicide and indeed, the adult clinical trial database does not demonstrate that Seroxat causes suicide, suicidal thinking or suicide attempts."
Dr Benbow said that in GSK's in-house trials, which included over 1,000 patients treated with paroxetine, not a single person committed suicide.
(GMcG)
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