CMO Urgent Communication: Safety of paroxetine
(Tuesday, 10th June 2003)

Prescribing advice on Seroxat for children and adolescents issued (REF: DH)

The Chief Medical Officer (CMO) has issued prescribing advice on paroxetine (Seroxat) following the publication of new evidence on the drug's safety and efficacy in children and adolescents under the age of 18 years. Paroxetine is not licensed for use in children but it is used in this age group outside the licensed indications.

Data from clinical trials in children and adolescents have been reviewed by an Expert Working Group on SSRIs and the Committee on Safety of Medicines (CSM). These data do not demonstrate efficacy in depressive illness in this age group and show an increase in the risk of harmful outcomes including episodes of self-harm and potentially suicidal behaviour in the Seroxat group compared to placebo. Various analyses suggest that the risk of these outcomes is between 1.5 and 3.2 times greater with Seroxat compared to placebo.

On the basis of these data, the CSM has advised that the balance of risks and benefits of Seroxat is unfavourable when used to treat depressive illness in this age group. The CSM has advised that Seroxat should not be used in children and adolescents under the age of 18 years to treat depressive illness. The efficacy and safety of Seroxat for children in other indications has not been established.

Prescribing advice children and adolescents with depressive illness:

  • Seroxat should not be prescribed as new therapy for patients under 18 years of age with depressive illness
  • If a patient is being successfully treated with Seroxat, then the completion of the planned treatment course should be considered as an option in the management of the illness
  • If a patient is not doing well on Seroxat, change of treatment should be considered.
When stopping treatment with Seroxat:
Seroxat should not be stopped suddenly because of the risk of withdrawal reactions. The dose should be reduced very gradually, using half tablets, and then alternating days, if necessary. If the dose is not tapered, there is a greater chance of experiencing side effects. For the majority of people, symptoms go away on their own within two weeks. If side effects are intolerable on dose reduction or stopping, the dose should be increased and subsequently reduced more gradually.

Adults:
Paroxetine has been demonstrated to be effective in adults with depressive illness and the CSM advises that the balance of risks and benefits of paroxetine remains positive. However, the implications of the new paediatric data on the safety of paroxetine in the adult population remains under close review by the CSM and its Expert Working Group.

Further information on Seroxat for prescribers and patients is available on the website of the Medicines and Health Care Products Regulatory Agency (MHRA). Should you require any additional information, please telephone the MHRA on 0207 273 0000.

REF: Department of Health, Richmond House, 79 Whitehall, London SW1A 2NS

Department of Health website
Clinnix is not responsible for the accuracy or availability of information on external websites.

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