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Seroxat warning to under-18s

Jun 10 2003

 

Under-18s should not be given the anti-depressant Seroxat as the risk of suicidal thoughts and self harm is up to three times higher among those on the drug, experts said.

The controversial drug is not licensed in the UK for children and teenagers but some doctors give the drug to treat depression based on their own judgement.

In the last year alone, 40,000 Seroxat prescriptions were written for under-18s - 7,000-8,000 children and adolescents were given the drug for depression.

But today the Medicines and Healthcare products Regulatory Agency (MHRA) said new data from manufacturers GlaxoSmithKline had now come to light which showed the drug was not effective at treating depression in this age group.

In addition, the nine studies - based on more than 1,000 children - had shown that the risk of suicidal thoughts and self harm was two to three times greater among those on Seroxat compared to those on a placebo drug.

The MHRA said it was important no one stopped taking the drug suddenly.

Patients who did so might see symptoms of their depression return and could suffer withdrawal symptoms, including an increased risk of suicide.

Teenagers and children on Seroxat were advised instead to consult their doctor.

The MHRA said the new data applied only to adolescents and children but its expert group would now consider if it had any implication for adults on Seroxat.

 
 

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