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EU-wide warnings loom for controversial anti-depressant

27 July 2004

Doctors across the European Union are expected to be issued with tough guidelines about prescribing a popular antidepressant, amid fears it boosts the risk of suicide and causes withdrawal symptoms, according to recommendations made by the EU's drugs agency.

The drug, paroxetine, is made by the pharmaceutical giant GlaxoSmithKline, which markets it under the brand name of Seroxat or Paxil.

It is widely prescribed to treat depression, obsessive/compulsive disorder, panic disorder, social anxiety and other symptoms.

The recommendations were made by the European Agency for the Evaluation of Medicinal Products (EMEA) after a 10-month inquiry into the advantages and risks from this medication, a spokesman for the EMEA said Tuesday.

In its assessment, the EMEA said "the benefit-risk remains positive" for paroxetine.

But, it said, the drug should not be used in children and adolescents, given that clinical trials had linked it with an increased risk of suicidal behaviour and hostility.

Doctors should also be aware of the potential for increased risk of suicide among young adults, and in addition beef up their warnings to patients about the risk of withdrawal symptoms, especially if they suddenly stop taking the drug.

The recommendations were made in April by the EMEA's Committee for Proprietary Medicinal Products, the spokesman said.

They have now been submitted to the European Commission which, if it gives its approval, means the recommendations will go out across the 25-nation EU.

The London-based EMEA's job is to harmonise regulations on the use of medicinal products across the EU so that there is a level playing field for manufacturers and common guidelines for doctors and patients.

It was asked for its opinion on paroxetine at the request of Britain.

Britain's national drug authority last year banned doctors from prescribing paroxetine to anyone under 18.

In March this year, the US Food and Drug Administration (FDA) issued a warning about paroxetine and nine other antidepressants, telling doctors to monitor all patients for any signs of worsening depression and obsession with suicide.

In June, New York Attorney General Eliot Spitzer sued GlaxoSmithKline for consumer fraud, charging the company with concealing negative information about paroxetine.

The civil lawsuit alleges the company failed to tell doctors that studies found the drug failed to work in adolescents and may be linked to some cases of suicide.

Web link: EMEA - European Agency for the Evaluation of Medicinal Products EMEA - European Agency for the Evaluation of Medicinal Products

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