Seroxat ‘should not be prescribed to children’
Department of Health officials today announced new ‘prescribing advice’ for the antidepressant Seroxat after researchers discovered a possible link between the drug and suicidal tendencies in children.
The Committee on Safety of Medicines (CSM) recommended that Seroxat, known as Paxil in the US, should not be prescribed for depressive illness to those under 18 years of age.
Before today’s recommendation, the drug was not licensed for prescription to under-18s but some doctors had the discretion to give the anti-depressant in some ‘off-label’ cases.
However, new data recently considered by the CSM showed that there was “an increase in the rate of self harm and potentially suicidal behaviour” in under 18s when Seroxat was used to treat depression.
“It has become clear that the benefits of Seroxat in children for the treatment of depressive illness do not outweigh these risks”, the CMS maintained.
Responding to the decision, the head of European psychiatry for GlaxoSmithKline (GSK) – which manufactures the drug – defended the safety record of the controversial anti depressant.
Dr Alastair Benbow told Channel Four’s ‘News at Noon’: ‘We have brought information today to the regulatory authorities on our paediatric clinical trials. In more than a thousand patients, there were no episodes on suicide.’
‘We believe that Seroxat has a very well established safety and efficacy profile that has been confirmed over many years around the world.’
‘We have conducted a range of different clinical trials in a number of different indications. We are currently further analysing the data with the regulatory authorities and we have compelling information from tens of millions of patients around the world in the adult population, and you should remember that Seroxat is not and has never been licensed for use in children.’
He added: ‘Depression is a terrible disease that affects one in seven of the population and causes more than 3000 avoidable deaths through suicide here in the UK.
“We believe that by providing medicines with a well established safety and efficacy programme, that will help reduce that devastating burden in the UK and around the world.’
For his part, the chairman of CSM, Professor Gordon Duff, accepted that the use of anti-depressants such as Seroxat was essential in treating depression in some adults.
But he stressed: ‘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.’
According to the Department of Health, approximately 4 million Seroxat prescriptions were issued and an estimated 8,000 patients under 18 years were treated wih Seroxat in the last year.
The CSM stresses that those currently taking Seroxat should not suddenly end treatment. Patients are being advised to discuss any concerns with their doctors.
GSK has come under fire over recent months following a series of Panorama documentaries which outline claims that the drug is linked with increased suicidal tendencies among adults as well as children. The company strongly disputes the allegations.
