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12:26 - 10 June 2003

Seroxat could cause young people under the age of 18 to commit suicide, say the Government, and doctors should stop prescribing it.

The unprecedented warning from the Government's regulatory authority comes after it was revealed that early clinical trials carried out by the antidepressant drug's manufacturers prove Seroxat can cause children and teenagers to self harm or even attempt suicide. But while the Medicines and Healthcare products Regulatory Agency (MHRA) warn patients under the age of 18 taking Seroxat to seek advice from their GP, they say Seroxat is still safe for adults.

Campaigners in Gloucestershire, who have been calling for the drug to be banned since last year, have welcomed the decision.

In what has been called 'a severe dressing down,' the MHRA's decision will come as a huge blow for drug giant GlaxoSmithKline, which continues to claim Seroxat is a safe and effective drug prescribed to millions of patients each year.

In a statement, the MHRA's Chairman, Professor Alasdair Breckenridge, said: " It has become clear that the benefits of Seroxat in children for the treatment of depressive illness do not outweigh these risks."

In the last year, around four million prescriptions were issued and an estimated 8,000 patients under 18 years were treated with Seroxat.

Although Seroxat is not licensed by the MHRA for children, GPs are allowed to use their own judgement to prescribe it when necessary.

Faye Elliott, founder of the Gloucestershire Seroxat Support Group, said: "Although we have successfully succeeded in forcing GSK to admit that Seroxat can cause self harming and suicidal thoughts in young people under the age of 18 years, we need for them to go that step further to admit that it can also cause these very same problems in adults."

Gloucester MP, Parmjit Dhanda, said: "This is a severe dressing down for GSK. This decision could save lives."

While the MHRA are warning all young patients using Seroxat to contact their GPs, an expert group of the Government's Committee on Safety of Medicines will be looking into what dangers Seroxat may pose for adults.

Professor Ian Weller, chairman of the expert group, said: "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."

No comment was available from GSK.

n It is essential that anyone taking Seroxat, whether child or adult, should not stop taking the drug.

If you are concerned about the effects of Seroxat, please contact your GP or NHS Direct on 0845 46 47.

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